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

IBS - Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509725
• Other study ID #: C-005
• Status: Recruiting
• Phase: Phase 4
• Start date: August 11, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Lallemand Health Solutions
• Contact: Burcu Sume
• Phone: +90 312 479 88 75
• Email: burcus[@]croturk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Probiotic formulation
Participants will be asked to take 2 doses daily
• Placebo
Participants will be asked to take 2 doses daily

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine, Gastroenterology Department	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Lallemand Health Solutions

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Abdominal Pain	Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)	8 weeks
Primary	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	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
Secondary	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
Secondary	Stool frequency	Measured as the average number of stools per week	up to 10 weeks
Secondary	Abdominal discomfort	Using questionnaire in participants diary	up to 10 weeks
Secondary	Perceived Stress	Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)	8 weeks
Secondary	Change in Irritable Bowel Syndrome Symptom Severity Scores	Using the The irritable bowel severity scoring system (IBS-SSS)	8 weeks