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

NCT05509725 | Recruiting Phase 4

• 1 other identifier: C-005
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

IBS-D; Probiotics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change Abdominal pain intensity

  up to 10 weeks

• Abnormal defecation consistency

  up to 10 weeks

• Stool frequency

  up to 10 weeks

• Abdominal discomfort

  up to 10 weeks

• Perceived Stress

  8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Probiotic formulation

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Probiotic formulation DRUG

Participants will be asked to take 2 doses daily

Intervention

Placebo DRUG

Participants will be asked to take 2 doses daily

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead

Study Sites (1)

Ege University Faculty of Medicine, Gastroenterology Department

Izmir, 35040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Serhat Bor, Prof. Dr.

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu Sume

CONTACT

+90 312 479 88 75; burcus@croturk.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: August 22, 2022
• Study Start: August 11, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)