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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Asian Institute of Gastroenterology, India.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Pratap Nitesh, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01638208
First received: July 6, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
Drug: VSL#3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spectrum of Gastrointestinal Microbiota in Patients With IBS-D Before and After Treatment With VSL#3.

Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3 [ Time Frame: 8 wks ] [ Designated as safety issue: No ]
    To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.


Secondary Outcome Measures:
  • Comparison of GI microbiota before and after treatment [ Time Frame: 8 wks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638208

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

Locations
India
Asian Institute of Gstroenterology Not yet recruiting
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

No publications provided

Responsible Party: Pratap Nitesh, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01638208     History of Changes
Other Study ID Numbers: AIG-VSL#3-IBS-NP
Study First Received: July 6, 2012
Last Updated: July 9, 2012
Health Authority: India: Central Drugs Standard Control Organization

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 27, 2014