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

• ClinicalTrials.gov Identifier: NCT01638208
• Recruitment Status: Unknown
• First Posted: July 11, 2012
• Last Update Posted: July 11, 2012
• Sponsor: Asian Institute of Gastroenterology, India
• Information provided by (Responsible Party): Pratap Nitesh, Asian Institute of Gastroenterology, India

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: VSL#3	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spectrum of Gastrointestinal Microbiota in Patients With IBS-D Before and After Treatment With VSL#3.
• Study Start Date: August 2012
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: VSL#3; Patients with IBS-D as per ROME III	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).; Other Name: probiotic
No Intervention: Healthy Controls; Healthy controls

Outcome Measures

Primary Outcome Measures :

1. Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3 [ Time Frame: 8 wks ]
   To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.

Secondary Outcome Measures :

1. Comparison of GI microbiota before and after treatment [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Dr. Nitesh Pratap, DM; 0091-9000150678; pratapnitesh@yahoo.com

Locations

India

Asian Institute of Gstroenterology

Hyderabad, Andhra Pradesh, India, 500082

Contact: Dr. Nitesh Pratap, DM 0091-9000150678 pratapnitesh@yahoo.com

Principal Investigator: Dr. Nitesh Pratap, DM

Sub-Investigator: Dr. Nageshwar Reddy, DM

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

• Principal Investigator: Dr. Nitesh Pratap, DM; Asian Institute of Gastroenterology
• Study Director: Dr. Nageshwar Reddy, DM; Asian Institute of Gastroenterology

More Information

• Responsible Party: Pratap Nitesh, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT01638208
• Other Study ID Numbers: AIG-VSL#3-IBS-NP
• First Posted: July 11, 2012
• Last Update Posted: July 11, 2012
• Last Verified: July 2012

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases