To study the relationship of gut microbes and Dietary habits of Indian subjects
- Registration Number
- CTRI/2015/01/005367
- Lead Sponsor
- ITC Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Must be able to provide the required information:
Dietary habit (Wheat eating/rice eating and veg/Non veg).
Ayurvedic doshas.
Ethnicity.
Health status.
Volunteers must be willing to provide blood and stool samples.
Have given the written informed consent for participation in the study.
Body mass index greater than or equal to 35 or less than or equal to 18. Blood sugar levels more than 120 before meals or 170 after meals for healthy volunteer selection. Vital signs outside of acceptable range at screening visit i.e. blood pressure >160/100, oral temperature > 37.6 C, pulse >100.
Use of any of the following drugs within the last 6 months:
Antibiotics.
Cytokines.
Immunosuppressive cytotoxic agents.
Large dose of Commercial Probiotic consumed in form of capsules etc. (>= 108cfu or organism per day). Dietary components such as yogurts, beverages etc do not apply.
Use of topical antibiotics within the previous 7 days.
Presence of a moderate or severe illness with or without fever.
Any medical history such as cancer etc.
Major changes in diet during the previous month.
History of chronic alcohol consumption.
History of any condition of immunosuppression including HIV.
Major surgery of GI tract.
Use of OTC medication in the last 3 months.
History of active uncontrolled GI disorders or disease including:
Inflammatory bowel disease (IBD), Crohnâ??s disease or indetermine colitis.
Irritable bowel syndrome (IBS).
Persistent infection in GI tract or chronic diarrhea.
Female who is pregnant or lactating.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ILTimepoint: NI
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI