This study aimed to assess the impact of consumption of COMBO, a combination product of two Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable Bowel Syndrome (IBS).
This is an open label study designed to assess the impact on stress, mood and bowel symptoms \& safety of COMBO, a combination of Bifidobacterium longum 35624® and Bifidobacterium longum 1714™ strains, when consumed once daily for 8 weeks, in adults with Irritable Bowel Syndrome (IBS). Volunteers will be screened according to the selection criteria in order to identify up to 40 female subjects, with recurrent abdominal pain/discomfort and mild to moderate stress/mood status. The study will involve 6 visits over an 18 to 20-week period \[Screening period (Visit 1: week-2), Intervention period (Visit 2: week 0, Visit 3: week 4, Visit 4: week 8), and Follow-up/ Washout period (Visit 5: week 12, Visit 6: week 16)\]. Participants will fill in daily and weekly eDiary from 1st visit onwards. Questionnaires will be administered from visit 2 to visit 6. Research blood and saliva will also be collected at these time points. Stool sample will be collected at Visit 2, 4, 5, 6.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Each probiotic capsule contains 5 x 10\^8 CFU B. longum 35624® and 5 x 10\^8 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsule will be supplied by PrecisionBiotics Ltd.
Atlantia Food Clinical Trials Ltd.
Cork, Ireland
Change in stress and mood, assessed by Hospital Anxiety and Depression Scale (HADS) scores
HADS gives HADS-A and HADS-D scores; minimum score for each is 0, maximum score is 21. Higher scores indicate worse stress/mood.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in Subject Global Assessment (SGA) of IBS symptoms, assessed by weekly eDiary
Participants answer the question: "Did you have adequate relief of your IBS symptoms over the past week?" Yes or No.
Time frame: Assessed weekly from baseline to 8 weeks post supplement intake.
Change in Subject Global Assessment (SGA) of abdominal pain/discomfort, assessed by weekly eDiary
Participants answer the question: "Did you have adequate relief of your abdominal pain and discomfort over the past week?" Yes or No.
Time frame: Assessed weekly from baseline to 8 weeks post supplement intake.
Change in IBS-Symptom Severity Score (IBS-SSS)
IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Scores range from 0 to 500, with higher scores indicating worse symptoms.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in stool frequency, assessed by daily eDiary
Daily diary of number of bowel movements.
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in stool consistency (Bristol Stool Scale), assessed by daily eDiary
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Daily diary of stool consistency of each bowel movement based on Bristol Stool Scale (Type 1-7).
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in abdominal pain/discomfort, assessed by daily eDiary
Daily diary of Visual Analog Scale (VAS) of abdominal pain/discomfort.
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in abdominal bloating/distension, assessed by daily eDiary
Daily diary of Visual Analog Scale (VAS) of abdominal bloating/distension.
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in bowel movement urgency, assessed by daily eDiary
Daily diary of Visual Analog Scale (VAS) of bowel movement urgency.
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in straining, assessed by daily eDiary
Daily diary of Visual Analog Scale (VAS) of straining.
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in passage of gas, assessed by daily eDiary
Daily diary of Visual Analog Scale (VAS) of passage of gas.
Time frame: Assessed daily from baseline to 8 weeks post supplement intake.
Change in Visceral Sensitivity Index
Visceral Sensitivity Index (VSI) is a self-report measure of the gastrointestinal symptom-specific anxiety (GSA) of patients with IBS, in terms of cognitive, emotional and behavioral responses. Sum scores range from 0 to 75 with higher scores indicating more severe GI-specific anxiety.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in sleep quality, assessed by Pittsburgh Sleep Quality Index (PSQI)
PSQI global score: minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in cognition, assessed by Visual Analogue Scales
This assessment measures individual question answers related to hedonic tone, anxiety and alertness.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in cognition, assessed by spatial span test
This test measures span length, errors, number of attempts and latency.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in cognition, assessed by Stockings of Cambridge test
This test measures problems solved in minimum moves, mean moves per n-move problem, initial thinking time per n-move problems and subsequent thinking time per n-move problems.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Change in cognition, assessed by Paired Associates Learning test
This test measures errors, trials, memory scores and stages completed.
Time frame: Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.
Safety of the investigational product, assessed by number of participants with treatment-related adverse events
Safety will be evaluated throughout the study on the basis of incidence of treatment-related serious and non-serious adverse events.
Time frame: Assessed through study completion, an average of 6 months.