Multi-strain Probiotic in the Management of IBS-D

NCT ID: NCT03251625

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

To assess the effect of multistrain probiotics on abdominal

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

Group Type: PLACEBO_COMPARATOR

Probiotic Formula Capsule

Intervention Type: DRUG

To assess the efficacy of a multistrain probiotic supplement

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

Group Type: PLACEBO_COMPARATOR

Probiotic Formula Capsule

Intervention Type: DRUG

Interventions

Probiotic Formula Capsule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

S M khosruzzaman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashton Harper, MRCS

Role: STUDY_DIRECTOR

Probiotics International Ltd (Protexin)

References

Ishaque SM, Khosruzzaman SM, Ahmed DS, Sah MP. A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult(R)) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterol. 2018 May 25;18(1):71. doi: 10.1186/s12876-018-0788-9.

Reference Type: DERIVED

PMID: 29801486 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

No. BSMMU/2015/1011

Identifier Type: -

Identifier Source: org_study_id