NCT05509725

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

Name: Clinical Trial NCT05509725
Creator: Lallemand Health Solutions
Keywords: IBS - Irritable Bowel Syndrome, Probiotic formulation, Phase 4, drug, clinical trial, Turkey

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

Lallemand Health Solutions·Phase 4·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: IBS - Irritable Bowel Syndrome
Drug/Device/Intervention: Probiotic formulation
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Lallemand Health Solutions
Location: İzmir, Turkey

Timeline & enrollment

Phase: Phase 4
Start date: Aug 11, 2022
End date: Sep 01, 2024
Enrollment: 162 participants

Primary outcome

Change in Abdominal Pain,Change in Defecation consistency

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.

ICD-10 classifications

Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndromeIrritable bowel syndrome with predominant diarrhoea [IBS-D]Irritable bowel syndrome with mixed bowel habits [IBS-M]Other and unspecified irritable bowel syndrome

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05509725
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05509725 through Pure Global AI's free database. This Phase 4 trial is sponsored by Lallemand Health Solutions and is currently Recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 162 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.