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

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Lallemand

Status and phase

Enrolling
Phase 4

Conditions

IBS - Irritable Bowel Syndrome

Treatments

Drug: Placebo
Drug: Probiotic formulation

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

162 participants in 2 patient groups, including a placebo group

Intervention
Experimental group
Description:
Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.
Treatment:
Drug: Probiotic formulation
Control
Placebo Comparator group
Description:
Participants in this group will be randomized to receive placebo for the following 8 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Burcu Sume

Data sourced from clinicaltrials.gov

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