Back to results

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

Primary Purpose

IBS - Irritable Bowel Syndrome

Status

Recruiting

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Probiotic formulation

Placebo

About this trial

This is an interventional supportive care trial for IBS - Irritable Bowel Syndrome focused on measuring IBS-D, Probiotics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Ege University Faculty of Medicine, Gastroenterology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Abdominal Pain

Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)

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)

Secondary Outcome Measures

Change Abdominal pain intensity

Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)

Abnormal defecation consistency

Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)

Stool frequency

Measured as the average number of stools per week

Abdominal discomfort

Using questionnaire in participants diary

Perceived Stress

Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)

Change in Irritable Bowel Syndrome Symptom Severity Scores

Using the The irritable bowel severity scoring system (IBS-SSS)

Full Information

NCT ID

NCT05509725

First Posted

July 1, 2022

Last Updated

February 1, 2023

Sponsor

Lallemand Health Solutions

1. Study Identification

Unique Protocol Identification Number

NCT05509725

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 11, 2022 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lallemand Health Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IBS - Irritable Bowel Syndrome

Keywords

IBS-D, Probiotics

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Probiotic formulation

Intervention Description

Participants will be asked to take 2 doses daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will be asked to take 2 doses daily

Primary Outcome Measure Information:

Title

Change in Abdominal Pain

Description

Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)

Time Frame

8 weeks

Title

Change in Defecation consistency

Description

Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change Abdominal pain intensity

Description

Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)

Time Frame

up to 10 weeks

Title

Abnormal defecation consistency

Description

Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)

Time Frame

up to 10 weeks

Title

Stool frequency

Description

Measured as the average number of stools per week

Time Frame

up to 10 weeks

Title

Abdominal discomfort

Description

Using questionnaire in participants diary

Time Frame

up to 10 weeks

Title

Perceived Stress

Description

Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)

Time Frame

8 weeks

Title

Change in Irritable Bowel Syndrome Symptom Severity Scores

Description

Using the The irritable bowel severity scoring system (IBS-SSS)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Burcu Sume

Phone

+90 312 479 88 75

burcus@croturk.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Serhat Bor, Prof. Dr.

Organizational Affiliation

Ege University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ege University Faculty of Medicine, Gastroenterology Department

City

İzmir

ZIP/Postal Code

35040

Country

Turkey

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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).

Learn more about this trial

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

We'll reach out to this number within 24 hrs