Multi-strain Probiotic in the Management of IBS-D

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Probiotic Formula Capsule

• Registration Number: NCT03251625
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-16
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
To assess the effect of multistrain probiotics on abdominal	Probiotic Formula Capsule	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 multistrain probiotic supplement	Probiotic Formula Capsule	To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre

Primary Outcome Measures

Name	Time	Method
The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo	1 year.	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.