This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).
This is a double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with IBS-D, when consumed orally in capsule form once daily for 84 days. Volunteers will be screened in order to identify up to 134 participants meeting ROME IV criteria for IBS-D. The study will involve 5 visits over a total of 105 days \[visit 1: screening, commencement of run in period (-21 to -14 days), visit 2: baseline/ randomisation (day 0), visits 3 and 4: intervention period (day 28 ± 2, day 56 ± 2), visit 5: end of study (day 84± 2)\]. Participants will fill in daily and weekly eDiaries, and questionnaires will be administered at study visits. Faecal samples will be collected on visits 2 and 5.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
46
Vizera
Ljubljana, Slovenia
Change in total irritable bowel syndrome symptom severity score (IBS-SSS)
Change in IBS-SSS totals score (max 500 points) from baseline to day 28, day 58 and day 84, where higher scores mean worse outcomes
Time frame: Day 0, Day 28, Day 58 and Day 84
Percentage of population achieving a normal stool consistency
Percentage of the population achieving normal stool consistency, defined as over 75% of total bowel movements classified as stool form type 3, 4, and 5 on Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage at baseline compared to weekly percentage at day 28, 58 and 84.
Time frame: Day 0, Day 28, Day 58 and Day 84
Percentage of population without diarrhea
Percentage of the population where less than 25% of bowel movements are diarrhea, defined as stool form type 6 or 7 on the Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage calculated throughout study and compared to baseline weekly percentage.
Time frame: Weekly
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Change in quality of life, assessed by change in the IBS-QOL total score (max 100 points) between baseline and day 28, day 58 and day 84, where higher scores mean better quality of life
Time frame: Day 0, Day 28, Day 58 and Day 84
Change in State-Trait Anxiety Inventory for Adults (STAI-AD) score
Mental health as assessed by change in STAI-AD S-anxiety subscale score (max: 80), between baseline and day 28, 58 and 84, where higher scores mean more severe anxiety symptoms
Time frame: Day 0, Day 28, Day 58 and Day 84
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Gut microbiome compositional changes
Change in gut microbiome composition, as assessed by shotgun sequencing of faecal samples, between baseline and study end (day 84)
Time frame: Day 0, Day 84
Use of Rescue Medication
Comparison in total cumulative use of rescue medications between the two study arms at study end (day 84)
Time frame: Day 0, Day 84