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

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ClinicalTrials.gov Identifier: NCT01638208
Recruitment Status : Unknown
Verified July 2012 by Pratap Nitesh, Asian Institute of Gastroenterology, India.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pratap Nitesh, 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.


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 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

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 11, 2012    Key Record Dates
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