Multi-strain Probiotic in the Management of IBS-D

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251625
• Other study ID #: No. BSMMU/2015/1011
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2017
• Last updated: February 1, 2018
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2018
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Probiotic Formula Capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.