A Randomized, Double Blind, Placebo Controlled, Parallel Group Clinical Study to Assess Effects of Postbiotic vs. Placebo in Participants With Moderate to Severe Diarrhea-predominant Irritable Bowel Syndrome

A-Mansia Biotech S.A.23 sites in 1 country384 target enrollmentJuly 18, 2024

ConditionsDiarrhea-Predominant Irritable Bowel Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
Sponsor: A-Mansia Biotech S.A.
Enrollment: 384
Locations: 23
Primary Endpoint: To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome.
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of postbiotic on anxiety, low mood and stress of the participants, as well as its safety and tolerability.

The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase).

Registry

clinicaltrials.gov

Start Date

July 18, 2024

End Date

July 13, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

A-Mansia Biotech S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women from 18 to 55 years old.
•Individuals diagnosed for IBS within the last two years, and meets Rome-IV criteria for IBS: recurrent abdominal pain on average ≥1 day/week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
•Related to defecation
•Associated with a change in frequency of stool
•Associated with a change in form (appearance) of stool.
•Has IBS-D, i.e., more than ¼ (25%) of bowel movements with Bristol stool types 6 or 7 and less than ¼ (25%) of bowel movements with Bristol stool types 1 or 2); in other words, put practically and as per FDA: at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS.
•Has an IBS-SSS of at least 175 points at screening.
•Individuals either with abdominal pain or discomfort (≥ 6 to ≤ 10 on an 11-point scale).
•Has had no prior line of conventional intervention for IBS or dietary change in the last 4 weeks before screening (e.g., low FODMAP, soluble fibers, antispasmodics, laxatives, obstipants, serotonin agonist/antagonist) i.e., recently diagnosed individuals
•Individuals' agreement to comply with study procedures, in particular:

Exclusion Criteria

•Known allergy or hypersensitivity to the components of the investigational product.
•Lactose or fructose intolerance.
•Individuals with uncontrolled hypertension as assessed by systolic blood pressure ≥ to 160 mmHg and diastolic blood pressure ≥ to 100mmHg.
•History of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aorto-iliac disease) or recent unexplained GI bleeding within 3 months prior to screening.
•History of malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
•History and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., inflammatory bowel disease, coeliac disease, Clostridium difficile colitis, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc.)
•Major gastric, hepatic, biliary, pancreas or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred \&gt; 3 months prior to study screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred \&gt; 3 months prior to screening).
•Clinically significant findings in colonoscopy within the 3 years prior to study.
•Family history among first degree relatives of colorectal cancer or inflammatory bowel disease.
•Individuals diagnosed with psychiatric disease (e.g., bipolar disorder, Schizophrenia) with or without medication in the last three years.

Outcomes

Primary Outcomes

To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome.

Time Frame: Baseline (Day 0), and Week 12 (Day 84)

A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)

Secondary Outcomes

To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8(Baseline (Day 0) and Week 8 (Day 56))
To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS)(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12.(Baseline (Day 0) and Week 12 (Day 84))
To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12.(Baseline (Day 0) and Week 12 (Day 84))
To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS)(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument.(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))