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

Tracking Information

• First Submitted Date: July 6, 2012
• First Posted Date: July 11, 2012
• Last Update Posted Date: July 11, 2012
• Study Start Date: August 2012
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 9, 2012)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 9, 2012)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Changes in Gastrointestinal Microbiota Using VSL#3 in Patients With IBS-D
• Official Title: Spectrum of Gastrointestinal Microbiota in Patients With IBS-D Before and After Treatment With VSL#3.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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).

Other Name: probiotic

Study Arms

• Experimental: VSL#3
  Patients with IBS-D as per ROME III
  Intervention: Drug: VSL#3
• No Intervention: Healthy Controls
  Healthy controls

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 9, 2012): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2012
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01638208
• Other Study ID Numbers: AIG-VSL#3-IBS-NP
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pratap Nitesh, Asian Institute of Gastroenterology, India
• Original Responsible Party: Same as current
• Current Study Sponsor: Asian Institute of Gastroenterology, India
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Asian Institute of Gastroenterology, India
• Verification Date: July 2012