Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS (NCT06346847) | Clinical Trial Compass
CompletedNot Applicable
Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS
India384 participantsStarted 2024-07-18
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexALL
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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).
Exclusion criteria
What they're measuring
1
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.
. Known allergy or hypersensitivity to the components of the investigational product.
✕. Smokers
✕. 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 \> 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 \> 3 months prior to screening).