Multi-strain Probiotic in the Management of IBS-D

Study Overview
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Brief Summary
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To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre

Detailed Description
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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 Title
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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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Probiotic Formula Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Agreed not to start any other drug unless clinically indicated. No antibiotics in previous 2 months of enrolment. Exclusion Criteria: 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) Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc Any previous gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized, double-blind, placebo-controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: To assess the effect of multistrain probiotics on abdominal<br>To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. | Drug: Probiotic Formula Capsule<br> <br> |
| Placebo Comparator: To assess the efficacy of a multistrain probiotic supplement<br>To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre | Drug: Probiotic Formula Capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo | The change in severity and frequency of abdominal pain as measured by IBS-Symptom Severity Scores during treatment with a multi-strain probiotic or placebo, and compared with baseline. | 1 year. |