Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Sponsor

Lallemand Health Solutions (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05509725

Collaborator

(none)

162

Enrollment

Location

Arms

24.7

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IBS - Irritable Bowel Syndrome	Drug: Probiotic formulation Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 11, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.	Drug: Probiotic formulation Participants will be asked to take 2 doses daily
Placebo Comparator: Control Participants in this group will be randomized to receive placebo for the following 8 weeks.	Drug: Placebo Participants will be asked to take 2 doses daily

Arm

Intervention/Treatment

Experimental: Intervention

Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.

Drug: Probiotic formulation

Participants will be asked to take 2 doses daily

Placebo Comparator: Control

Participants in this group will be randomized to receive placebo for the following 8 weeks.

Drug: Placebo

Participants will be asked to take 2 doses daily

Outcome Measures

Primary Outcome Measures

Change in Abdominal Pain [8 weeks]
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Change in Defecation consistency [8 weeks]
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)

Secondary Outcome Measures

Change Abdominal pain intensity [up to 10 weeks]
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Abnormal defecation consistency [up to 10 weeks]
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Stool frequency [up to 10 weeks]
Measured as the average number of stools per week
Abdominal discomfort [up to 10 weeks]
Using questionnaire in participants diary
Perceived Stress [8 weeks]
Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)
Change in Irritable Bowel Syndrome Symptom Severity Scores [8 weeks]
Using the The irritable bowel severity scoring system (IBS-SSS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University Faculty of Medicine, Gastroenterology Department	İzmir		Turkey	35040

Sponsors and Collaborators

Lallemand Health Solutions

Investigators

Principal Investigator: Serhat Bor, Prof. Dr., Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lallemand Health Solutions

ClinicalTrials.gov Identifier:

NCT05509725

Other Study ID Numbers:

C-005

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lallemand Health Solutions

IBS-D

Probiotics

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Diarrhea

Study Results

No Results Posted as of Aug 22, 2022