Changes in Gastrointestinal Microbiota Using VSL#3 in Patients With IBS-D

Phase 4

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: VSL#3

• Registration Number: NCT01638208
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

Aim

To compare changes in gut microbiota of IBS patients and healthy controls using next generation sequencing method like Illumina sequencing based on 16S rDNA profiling.

The major objectives of the study are:

To characterize type of bacterial species and compare diversity of the host's gut microbiota in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high through put culture-independent method like Illumina sequencing.

To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.

To study the improvement of symptoms after modulation of gut microbiota with probiotics (VSL #3) for more than 8 weeks.

Detailed Description

Introduction

The role of the commensal flora in many disease states, including irritable bowel syndrome, inflammatory bowel disease, and even obesity, is now accepted and will undoubtedly lead to new therapeutic strategies. The recently NIH-initiated Human Microbiome Project will allow better understanding of the role of this complex intestinal community in human health and disease. On the clinical side, we are exploring the more common pathogenic bacterial strains in Irritable bowel syndrome patients and use of probiotics in this functional gastrointestinal disease. We are taking support from Genotypic institute, Bangalore for Illumina sequencing facility.

Asian Institute of Gastroenterology, the parent institution, is a 200 bed tertiary care referral hospital providing services to patients with GI diseases, with a daily attendance of 400 out-patients and 200 in-patients. The long term goals of the investigators, involving basic researchers and clinicians, include development of technological resources and applications of biotechnology for use in clinical trials to improve survival rates of patients with GI diseases. The major volume of the outpatient cases comprise of patients with irritable bowel syndrome. Altered GI microbiota may contribute to IBS symptoms and studying dysbiosis in gut microbiota is an important to develop therapy for IBS.

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-09
• Last Update Submitted: 2012-07-09
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11
• Study Start: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients satisfying Rome III Criteria

Exclusion Criteria

• Antimicrobial medication during last 2 months
• Probiotics medication during last 2 months
• Pregnant or lactating patients
• Previous major or complicated abdominal surgery
• Positive test for HIV, HBV or HCV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VSL#3	VSL#3	Patients with IBS-D as per ROME III

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3	8 wks	To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Comparison of GI microbiota before and after treatment	8 wks	To characterize type of bacterial species and compare diversity of the host's gut microbiota in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high through put culture-independent method like Illumina sequencing.

Trial Locations

Locations (1)

Asian Institute of Gstroenterology; 🇮🇳 Hyderabad, Andhra Pradesh, India