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

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

NCT05509725

C-005

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

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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