Multi-strain Probiotic in the Management of IBS-D

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh400 enrolled

Overview

1. To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. 2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Irritable Bowel Syndrome

Interventions

Probiotic Formula CapsuleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed case of IBS using Rome III criteria 2. Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer 3. Age 18-55 years 4. No probiotics used in prior 3 months. 5. Agreed not to start any other drug unless clinically indicated. 6. No antibiotics in previous 2 months of enrolment. Exclusion Criteria: 1. Age\<18 or \>55 years 2. Previous treatment with probiotics within last 3 months 3. Pregnant or lactating females 4. Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism) 5. Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc 6. Any previous gastrointestinal surgery

Outcomes

Primary Outcomes

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.

Time frame: 1 year.

Data from ClinicalTrials.gov

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