Completed

Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial

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What is being tested

Probiotic Formula Capsule

Drug
Who is being recruted

Colonic Diseases+3

+ Colonic Diseases, Functional

+ Digestive System Diseases

From 18 to 55 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2015
See protocol details

Summary

Principal SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2015

Actual date on which the first participant was enrolled.

Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms. Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.

Official TitleSupplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial
NCT03251625
Principal SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesIrritable Bowel Syndrome

Criteria

6 inclusion criteria required to participate
Diagnosed case of IBS using Rome III criteria
Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer
Age 18-55 years
No probiotics used in prior 3 months.
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6 exclusion criteria prevent from participating
Age<18 or >55 years
Previous treatment with probiotics within last 3 months
Pregnant or lactating females
Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

100% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.

Group II

Placebo
To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers