Multi-strain Probiotic in the Management of IBS-D

NCT03251625 | Completed Phase 4

• 1 other identifier: No. BSMMU/2015/1011
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

To assess the effect of multistrain probiotics on abdominal

PLACEBO COMPARATOR

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

Drug: Probiotic Formula Capsule

To assess the efficacy of a multistrain probiotic supplement

PLACEBO COMPARATOR

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

Drug: Probiotic Formula Capsule

Interventions

Probiotic Formula Capsule DRUG

To assess the effect of multistrain probiotics on abdominal; To assess the efficacy of a multistrain probiotic supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Related Publications (1)

• 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.

  PMID: 29801486 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ashton Harper, MRCS

  Probiotics International Ltd (Protexin)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants divided into two groups by randomization software, consisting of 200 in each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 16, 2017
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-02