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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSL#3 | Experimental | Patients with IBS-D as per ROME III |
|
| Healthy Controls | No Intervention | Healthy controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of GI microbiota before and after treatment | 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. | 8 wks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nitesh Pratap, DM | Contact | 0091-9000150678 | pratapnitesh@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Nitesh Pratap, DM | Asian Institute of Gastroenterology | Principal Investigator |
| Dr. Nageshwar Reddy, DM | Asian Institute of Gastroenterology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gstroenterology | Hyderabad | Andhra Pradesh | 500082 | India |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| D004066 | Digestive System Diseases |
| D019602 |
| Food and Beverages |