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

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

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.

Study Overview

• Status: Recruiting
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Probiotic formulation; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Burcu Sume; Phone Number: +90 312 479 88 75; Email: burcus@croturk.com

Study Locations

• Turkey
  • İzmir, Turkey, 35040
    • Recruiting
    • Ege University Faculty of Medicine, Gastroenterology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Investigators: Principal Investigator: Serhat Bor, Prof. Dr., Ege University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; IBS-D
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: C-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No