A randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of 8 weeks of supplementation with Bifidobacterium longum 1714® strain on Beck's Depression Inventory-II Score in adults who experience low mood.
This is a randomized, double-blind, placebo-controlled, parallel group study, designed to assess the effectiveness \& safety of Bifidobacterium longum 1714® strain in people with low mood. The 8-week intervention study will be conducted in 168 adults, aged ≥18 to ≤70 years, who experience low mood, and experience mild or moderate depression, according to the Beck's Depression Inventory II (Total score 14-28). The study will consist of 4 visits over a 10 week period commencing with a screening visit. The second visit will be the baseline (start of intervention - either active or placebo), followed by third (mid-intervention), fourth (end of treatment). Questionnaires will be administered from the first to the fifth visit and safety and research bloods will be collected at each visit throughout the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
168
Probiotic capsules containing 5 x 10\^9 CFUs, corn-starch and magnesium stearate.
Capsules containing corn-starch and magnesium stearate only.
Atlantia Food Clinical Trials
Cork, Ireland
Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Time frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in depression severity category assessed by the Patient Health Questionnaire-9 (PHQ-9)
Depression Severity category scores are as follows: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in fatigue assessed by the Visual Analogue Scale (VAS) for fatigue.
The instrument possesses 18 items which has two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). Each item is scored from 0-100 with higher scores indicating more fatigue or more energy.
Time frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score
Minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.
Time frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in stress assessed by the by Cohen's Perceived Stress Scale (PSS)
The PSS is a 14 item questionnaire with each item scored from 0-4. The total score ranges from 0-56 with a higher score indication more stress.
Time frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in quality of life assessed by the Short Form-36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The SF-36 is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Time frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Time frame: Change from baseline compared to placebo, assessed at 4 weeks of supplement intake
Changes in mood category assessed by the Beck Depression Inventory (BDI-II)
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Time frame: Change from baseline compared to placebo, assessed at 4 weeks of supplement intake