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.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 11, 2012
July 1, 2012
4 months
July 6, 2012
July 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3
To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.
8 wks
Secondary Outcomes (1)
Comparison of GI microbiota before and after treatment
8 wks
Study Arms (2)
VSL#3
EXPERIMENTALPatients with IBS-D as per ROME III
Healthy Controls
NO INTERVENTIONHealthy controls
Interventions
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).
Eligibility Criteria
You may qualify if:
- Patients satisfying Rome III Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asian Institute of Gstroenterology
Hyderabad, Andhra Pradesh, 500082, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Nitesh Pratap, DM
Asian Institute of Gastroenterology
- STUDY DIRECTOR
Dr. Nageshwar Reddy, DM
Asian Institute of Gastroenterology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Gastroenterologist
Study Record Dates
First Submitted
July 6, 2012
First Posted
July 11, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 11, 2012
Record last verified: 2012-07