The goal of this project is to develop probiotic dietary supplements intended for the elderly, which can modify the composition of the intestinal microbiota typically occurring in the aging population. According to currently held scientific knowledge, it is postulated that the probiotics-induced normalization of the physiological axis in the brain-intestinal microbiota affects the activity of the nervous system. Thus, normalization of this axis should lead to observable improvements in cognitive functions and quality of life.
With an increasing age of the population, the incidence of age-related problems, such as memory deficits or negative changes in mood, is on the rise. On this account, an increased emphasis has been placed on identifying natural ways to reduce the occurrence of such problems. One of the proposed methods to achieve this is to modify the composition of gut bacteria and their by-products, which has shown a surprising, yet highly promising potential to benefit the brain function and blood composition. In the recent years, gut bacteria have been of great interest to many medical professionals from various disciplines. It is postulated that they might exert some influence on memory and emotions, but there is a lack of evidence to confirm these hypotheses. Our study would like to address this issue and examine the beneficial effects of probiotics into more depth. Probiotics are dietary supplements in the form of bacteria, which are often artificially added e.g. into some dairy products. This is done to promote gut health and to improve the quality of gut microflora. The subject selection and assessment are summarised as follows: Participants will be pre-selected electronically and given an electronic memory test. Further selection of eligible subjects based on their preliminary results will be followed by the first personal appointment, where each participant will undergo memory and mood-focused psychological testing and testing for gut bacteria composition. One week after the initial appointment, participants will be asked to bring in a stool and urine sample, their blood will be collected and their fitness and dietary habits assessed. Each participant will also be given an electronic watch, which will monitor their physical activity, and supplements in the pill form, which either contain specially cultivated human gut bacteria (i.e. probiotics) or placebo. Identical tests and blood, urine and stool collection will be repeated three months after administering the first pill. The participants will receive another set of pills, which will contain the probiotics if the participant has initially received placebo and vice versa. After three more months, participants will be subjected to the same tests as in the previous two instants. To test for lasting effects of treatment, participants will be tested again after 3 more months and the project will reach its termination. Using the above-mentioned methods, the aim of this project is to provide sufficient evidence of the beneficial effects of the new probiotics on memory, mood and the biochemical components contained in the blood, stool and urine in elderly population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
90
Probiotics will supplement normal diet. Unlike other products available on the market, which are usually of bovine origin, our probiotic has been manufactured using human-stemmed lines. The supplements are composed of a mixture of naturally occurring human gut bacteria.
University Hospital Vinohrady
Prague, Czechia
National Institute of Mental Health, Czech Republic
Prague, Czechia
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Time frame: baseline to 3 months
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Time frame: baseline to 6 months
Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Time frame: 3 months to 6 months
Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Time frame: 6 months to 9 months
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Time frame: 3 months
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Time frame: 6 months
Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months
ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Time frame: baseline to 3 months
Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months
ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Time frame: baseline to 6 months
Change from 3 months cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months
ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Time frame: 3 months to 6 months
Change from 6 months cognitive function in the Assessment Battery of Cognition (ABACO) at 9 months
ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Time frame: 6 months to 9 months
Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Time frame: 3 months
Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Time frame: 6 months
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Time frame: baseline to 3 months
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Time frame: baseline to 6 months
Change from 3 months cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Time frame: 3 months to 6 months
Change from 6 months cognitive function in Semantic word recollection (category: animals, 1 min) at 9 months
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Time frame: 6 months to 9 months
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Time frame: 3 months
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Time frame: 6 months
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
Time frame: baseline to 3 months
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
Time frame: baseline to 6 months
Change from 3 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
Time frame: 3 months to 6 months
Change from 6 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 9 months
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
Time frame: 6 months to 9 months
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
Time frame: 3 months
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm
Time frame: 6 months
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
Time frame: baseline to 3 months
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
Time frame: baseline to 6 months
Change in 3 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
Time frame: 3 months to 6 months
Change in 6 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 9 months
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
Time frame: 6 months to 9 months
Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
Time frame: 3 months
Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome
Time frame: 6 months
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months
The TMT is a validated measure of cognitive function, the time upon completion is measured
Time frame: baseline to 3 months
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 6 months
The TMT is a validated measure of cognitive function, the time upon completion is measured
Time frame: baseline to 6 months
Change in 3 month cognitive function in Trail Making Test (TMT), Parts A & B at 6 months
The TMT is a validated measure of cognitive function, the time upon completion is measured
Time frame: 3 months to 6 months
Change in 6 month cognitive function in Trail Making Test (TMT), Parts A & B at 9 months
The TMT is a validated measure of cognitive function, the time upon completion is measured
Time frame: 6 months to 9 months
Difference cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
The TMT is a validated measure of cognitive function, the time upon completion is measured
Time frame: 3 months
Difference cognitive function in Trail Making Test (TMT), Parts A & B at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
The TMT is a validated measure of cognitive function, the time upon completion is measured
Time frame: 6 months
Change in baseline mood in Geriatric Depression Scale at 3 months.
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Time frame: baseline to 3 months
Change in baseline mood in Geriatric Depression Scale at 6 months.
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Time frame: baseline to 6 months
Change in 3 month mood in Geriatric Depression Scale at 6 months.
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Time frame: 3 months to 6 months
Change in 6 month mood in Geriatric Depression Scale at 9 months.
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Time frame: 6 months to 9 months
Difference in mood in Geriatric Depression Scale at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Time frame: 3 months
Difference in mood in Geriatric Depression Scale at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Time frame: 6 months
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
Time frame: baseline to 3 months
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
Time frame: baseline to 6 months
Change from 3 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
Time frame: 3 months to 6 months
Change from 6 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 9 months
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
Time frame: 6 months to 9 months
Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
Time frame: 3 months
Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome
Time frame: 6 months
Changes in tau protein
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: baseline to 3 months
Changes in tau protein
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: baseline to 6 months
Changes in tau protein
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: 3 months to 6 months
Changes in tau protein
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: 6 months to 9 months
Changes in neurofilament light levels
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: baseline to 3 months
Changes in neurofilament light levels
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: baseline to 6 months
Changes in neurofilament light levels
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: 3 months to 6 months
Changes in neurofilament light levels
Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: 6 months to 9 months
Changes in immunocomplex antibody levels
Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: baseline to 3 months
Changes in immunocomplex antibody levels
Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: baseline to 6 months
Changes in immunocomplex antibody levels
Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: 3 months to 6 months
Changes in immunocomplex antibody levels
Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Time frame: 6 months to 9 months
Biochemical parameters in blood
Change from baseline Blood metabolome assessed using mass spectrometry at 3 months
Time frame: baseline to 3 months
Biochemical parameters in blood
Change from baseline Blood metabolome assessed using mass spectrometry at 6 months
Time frame: baseline to 6 months
Biochemical parameters in blood
Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months
Time frame: 3 months to 6 months
Biochemical parameters in blood
Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months
Time frame: 6 months to 9 months
Biochemical parameters in urine
15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 3 months
Time frame: baseline to 3 months
Biochemical parameters in urine
15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 6 months
Time frame: baseline to 6 months
Biochemical parameters in urine
15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months
Time frame: 3 months to 6 months
Biochemical parameters in urine
15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months
Time frame: 6 months to 9 months
Biochemical parameters in stool
Change from baseline Stool metabolome assessed using mass spectrometry at 3 months
Time frame: baseline to 3 months
Biochemical parameters in stool
Change from baseline Stool metabolome assessed using mass spectrometry at 6 months
Time frame: baseline to 6 months
Biochemical parameters in stool
Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months
Time frame: 3 months to 6 months
Biochemical parameters in stool
Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months
Time frame: 6 months to 9 months
Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months
DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Time frame: baseline to 3 months
Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months
DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Time frame: baseline to 6 months
Change from 3 months Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months
DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Time frame: 3 months to 6 months
Change from 6 months Questionnaire of adverse events (abbreviation in original language: DNU) at 9 months
DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Time frame: 6 months to 9 months
Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Time frame: 3 months
Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Time frame: 6 months
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Change from baseline Self-assessment of memory at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of memory at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of memory at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of memory at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of memory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months
Difference in Self-assessment of memory at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months
Change from baseline Self-assessment of digestion at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of digestion at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of digestion at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of digestion at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of digestion at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months
Difference in Self-assessment of digestion at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months
Change from baseline Self-assessment of overall health at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of overall health at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of overall health at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of overall health at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of overall health at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months
Difference in Self-assessment of overall health at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months
Change from baseline Self-assessment of sleep quality at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of sleep quality at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of sleep quality at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of sleep quality at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of sleep quality at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months
Difference in Self-assessment of sleep quality at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months
Change from baseline Self-assessment of anxiety at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of anxiety at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of anxiety at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of anxiety at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of anxiety at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 3 months
Difference in Self-assessment of anxiety at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 6 months
Change from baseline Self-assessment of fatigue at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of fatigue at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of fatigue at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of fatigue at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of fatigue at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 3 months
Difference in Self-assessment of fatigue at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Time frame: 6 months
Change from baseline Self-assessment of pain at 3 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 3 months
Change from baseline Self-assessment of pain at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: baseline to 6 months
Change from 3 months Self-assessment of pain at 6 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months to 6 months
Change from 6 months Self-assessment of pain at 9 months
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months to 9 months
Difference in Self-assessment of pain at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 3 months
Difference in Self-assessment of pain at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Time frame: 6 months
Change from baseline physical condition assessment in 30 second sit stand test at 3 months
Number of sits and stands during 30 seconds
Time frame: baseline to 3 months
Change from baseline physical condition assessment in 30 second sit stand test at 6 months
Number of sits and stands during 30 seconds
Time frame: baseline to 6 months
Change from 3 months physical condition assessment in 30 second sit stand test at 6 months
Number of sits and stands during 30 seconds
Time frame: 3 months to 6 months
Change from 6 months physical condition assessment in 30 second sit stand test at 9 months
Number of sits and stands during 30 seconds
Time frame: 6 months to 9 months
Difference in physical condition assessment in 30 second sit stand test at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Number of sits and stands during 30 seconds
Time frame: 3 months
Difference in physical condition assessment in 30 second sit stand test at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Number of sits and stands during 30 seconds
Time frame: 6 months
Change from baseline physical condition assessment in 30 second dumbell lift tests at 3 months
Number lifts during 30 seconds
Time frame: baseline to 3 months
Change from baseline physical condition assessment in 30 second dumbell lift tests at 6 months
Number lifts during 30 seconds
Time frame: baseline to 6 months
Change from 3 months physical condition assessment in 30 second dumbell lift tests at 6 months
Number lifts during 30 seconds
Time frame: 3 months to 6 months
Change from 6 months physical condition assessment in 30 second dumbell lift tests at 9 months
Number lifts during 30 seconds
Time frame: 6 months to 9 months
Difference in physical condition assessment in 30 second dumbell lift tests at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Number lifts during 30 seconds
Time frame: 3 months
Difference in physical condition assessment in 30 second dumbell lift tests at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Number lifts during 30 seconds
Time frame: 6 months
Change from baseline physical condition assessment in 30 meters walk at 3 months
Time untill completion
Time frame: baseline to 3 months
Change from baseline physical condition assessment in 30 meters walk at 6 months
Time untill completion
Time frame: baseline to 6 months
Change from 3 months physical condition assessment in 30 meters walk at 6 months
Time untill completion
Time frame: 3 months to 6 months
Change from 6 months physical condition assessment in 30 meters walk at 9 months
Time untill completion
Time frame: 6 months to 9 months
Difference in physical condition assessment in 30 meters walk at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Time untill completion
Time frame: 3 months
Difference in physical condition assessment in 30 meters walk at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Time untill completion
Time frame: 6 months
Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months
Structured self-report questionnaire
Time frame: baseline to 3 months
Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months
Structured self-report questionnaire
Time frame: baseline to 6 months
Change from 3 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months
Structured self-report questionnaire
Time frame: 3 months to 6 months
Change from 6 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 9 months
Structured self-report questionnaire
Time frame: 6 months to 9 months
Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Structured self-report questionnaire
Time frame: 3 months
Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Structured self-report questionnaire
Time frame: 6 months
Change in baseline Beck's Anxienty Inventory at 3 months
Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Time frame: baseline to 3 months
Change in baseline Beck's Anxienty Inventory at 6 months
Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Time frame: baseline to 6 months
Change in 3 months Beck's Anxienty Inventory at 6 months
Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Time frame: 3 months to 6 months
Change in 6 months Beck's Anxienty Inventory at 9 months
Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Time frame: 6 months to 9 months
Difference in Beck's Anxienty Inventory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Time frame: 3 months
Difference in Beck's Anxienty Inventory (BAI) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Time frame: 6 months
Change in baseline Beck's Depression Inventory - II (BDI-II) at 3 months
BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Time frame: baseline to 3 months
Change in baseline Beck's Depression Inventory - II (BDI-II) at 6 months
BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Time frame: baseline to 6 months
Change in 3 months Beck's Depression Inventory - II (BDI-II) at 6 months
BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Time frame: 3 months to 6 months
Change in 6 months Beck's Depression Inventory - II (BDI-II) at 9 months
BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Time frame: 6 months to 9 months
Difference in Beck's Depression Inventory - II (BDI-II) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Time frame: 3 months
Difference in Beck's Depression Inventory - II (BDI-II) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Time frame: 6 months