Clinical trial NCT05509725: Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Official title: Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: IBS - Irritable Bowel Syndrome
Keywords: IBS-D
Probiotics
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.

Detailed description: To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.

Eligibility criteria: Inclusion Criteria:

* Experiencing symptoms of IBS-D
* Having a diagnosis of IBS-D based on Rome IV criteria
* Participants with symptom onset at least 6 months before diagnosis
* Having a normal colonoscopy result in their medical file

Exclusion Criteria:

* A history of inflammatory or immune-mediated gastrointestinal diseases
* Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
* Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
* Currently diagnosed with an eating disorder,
* Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
* Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,
* Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is \> once per month a one month wash out is needed,
* Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,
* Pregnant, breast-feeding or planning on becoming pregnant.

Primary outcomes:
measure: Change in Abdominal Pain
timeFrame: 8 weeks
measure: Change in Defecation consistency
timeFrame: 8 weeks
Secondary outcomes:
measure: Change Abdominal pain intensity
timeFrame: up to 10 weeks
measure: Abnormal defecation consistency
timeFrame: up to 10 weeks
measure: Stool frequency
timeFrame: up to 10 weeks
measure: Abdominal discomfort
timeFrame: up to 10 weeks
measure: Perceived Stress
timeFrame: 8 weeks
measure: Change in Irritable Bowel Syndrome Symptom Severity Scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine, Gastroenterology Department
Study officials:
affiliation: Ege University
name: Serhat Bor, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: