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

Last updated: February 16, 2024
Sponsor: Lallemand Health Solutions
Overall Status: Active - Recruiting

Phase

4

Condition

Colic

Hyponatremia

Lactose Intolerance

Treatment

Placebo

Probiotic formulation

Clinical Study ID

NCT05509725
C-005
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • A history of inflammatory or immune-mediated gastrointestinal diseases
  • Diagnosed with a co-existing organic gastrointestinal disease which can affect thestudy
  • 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 exceptionof hernia repair or appendectomy
  • Currently diagnosed with any mood- or anxiety-related disorder, major psychiatricillness, or participants with a history of suicidal ideation, or current suicidalideation,
  • Regular use of anti-diarrhea medications and laxatives however occasional use ispermitted (≤ than once a month); if current use is > once per month a one month washout is needed,
  • Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-neededbasis" during the full length of the study,
  • Pregnant, breast-feeding or planning on becoming pregnant.

Study Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
August 11, 2022
Estimated Completion Date:
November 30, 2024

Study 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.

Connect with a study center

  • Ege University Faculty of Medicine, Gastroenterology Department

    İzmir, 35040
    Turkey

    Active - Recruiting

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