History of Changes for Study: NCT01638208

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

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Version	A	B	Submitted Date	Changes
1			July 9, 2012	None (earliest Version on record)

Study Identification


Unique Protocol ID:	AIG-VSL#3-IBS-NP
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.
Secondary IDs:

Study Status


Record Verification:	July 2012
Overall Status:	Unknown status [Previously: Not yet recruiting]
Study Start:	August 2012
Primary Completion:	December 2012 [Anticipated]
Study Completion:	December 2012 [Anticipated]

First Submitted:	July 6, 2012
First Submitted that Met QC Criteria:	July 9, 2012
First Posted:	July 11, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	July 9, 2012
Last Update Posted:	July 11, 2012 [Estimate]

Sponsor/Collaborators


Sponsor:	Asian Institute of Gastroenterology, India
Responsible Party:	Principal Investigator Investigator: Pratap Nitesh Official Title: Consultant Gastroenterologist Affiliation: Asian Institute of Gastroenterology, India
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

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.

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.

Conditions


Conditions:	Irritable Bowel Syndrome
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 4
Interventional Study Model:	Single Group Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	40 [Anticipated]

Arms and Interventions

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 Names:

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


Minimum Age:	18 Years
Maximum Age:	60 Years
Sex:	All
Gender Based:
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/Locations


Study Officials:	Dr. Nitesh Pratap, DM Principal Investigator Asian Institute of Gastroenterology
	Dr. Nageshwar Reddy, DM Study Director Asian Institute of Gastroenterology
Locations:	India, Andhra Pradesh
	Asian Institute of Gstroenterology Hyderabad, Andhra Pradesh, India, 500082 Contact:Contact: Dr. Nitesh Pratap, DM 0091-9000150678 pratapnitesh@yahoo.com Contact:Principal Investigator: Dr. Nitesh Pratap, DM Contact:Sub-Investigator: Dr. Nageshwar Reddy, DM

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: