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

Irritable Bowel Syndrome Clinical Trial

Official title:

Spectrum of Gastrointestinal Microbiota in Patients With IBS-D Before and After Treatment With VSL#3.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01638208
• Other study ID #: AIG-VSL#3-IBS-NP
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 6, 2012
• Last updated: July 9, 2012
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Asian Institute of Gastroenterology, India
• Contact: Dr. Nitesh Pratap, DM
• Phone: 0091-9000150678
• Email: pratapnitesh[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: Central Drugs Standard Control Organization
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• VSL#3
Dosage Form: Capsules (Details as given below); Dose and duration of treatment: 1 capsule b.i.d for 8 weeks; Each capsule contains 112.5 Billion CFU of the following 8 strains of bacteria, 4 lactobacilli strains (L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp bulgaricus), 3 bifidobacteria strains (B. breve, B. infantis, B. longum) and 1 strain of S. thermophilus).

Locations

Country	Name	City	State
India	Asian Institute of Gstroenterology	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3	To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.	8 wks	No
Secondary	Comparison of GI microbiota before and after treatment	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.	8 wks	No