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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Pratap Nitesh, Asian Institute of Gastroenterology, India.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01638208
First Posted: July 11, 2012
Last Update Posted: July 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pratap Nitesh, Asian Institute of Gastroenterology, India
July 6, 2012
July 11, 2012
July 11, 2012
August 2012
December 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Changes in Gastrointestinal Microbiota Using VSL#3 in Patients With IBS-D
Spectrum of Gastrointestinal Microbiota in Patients With IBS-D Before and After Treatment With VSL#3.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Irritable Bowel Syndrome
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
  • Experimental: VSL#3
    Patients with IBS-D as per ROME III
    Intervention: Drug: VSL#3
  • No Intervention: Healthy Controls
    Healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01638208
AIG-VSL#3-IBS-NP
No
Not Provided
Not Provided
Pratap Nitesh, Asian Institute of Gastroenterology, India
Asian Institute of Gastroenterology, India
Not Provided
Principal Investigator: Dr. Nitesh Pratap, DM Asian Institute of Gastroenterology
Study Director: Dr. Nageshwar Reddy, DM Asian Institute of Gastroenterology
Asian Institute of Gastroenterology, India
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP