Changes in Gastrointestinal Microbiota Using VSL#3 in Patients With IBS-D
NCT ID: NCT01638208
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2012-08-31
2012-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VSL#3
Patients with IBS-D as per ROME III
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).
Healthy Controls
Healthy controls
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Probiotics medication during last 2 months
* Pregnant or lactating patients
* Previous major or complicated abdominal surgery
* Positive test for HIV, HBV or HCV
18 Years
60 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Pratap Nitesh
Consultant Gastroenterologist
Principal Investigators
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Dr. Nitesh Pratap, DM
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Dr. Nageshwar Reddy, DM
Role: STUDY_DIRECTOR
Asian Institute of Gastroenterology
Locations
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Asian Institute of Gstroenterology
Hyderabad, Andhra Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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Dr. Nitesh Pratap, DM
Role: primary
Other Identifiers
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AIG-VSL#3-IBS-NP
Identifier Type: -
Identifier Source: org_study_id