Trial on pro-biotic health supplement for high altitude areas

Phase 3

• Registration Number: CTRI/2022/09/045812
• Lead Sponsor: Defence Institute of Physiology and Allied Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

BMI: 18-27

No antibiotic treatment in last 3 months

No history of gastro-intestinal disease

Maintenance of oral hygiene

Exclusion Criteria

Subjects with pre-existing clinically identified digestive and GI tract disease including Chrones.

History of Bariatric surgery or intestinal injury

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Homeostasis of gut and oral microbiota ascertained through sequencing analysisTimepoint: Baseline at o months and monthly follow up for 06 months

Secondary Outcome Measures

Name	Time	Method
Effect on physiological and biochemical parameters that are reported previously to be influenced by gut microbiota in scientific literature. Viz., Immunological: Cytokine, Chemokine, Immunoglobulin and complement factor profiling, Metabolic: Glucose, Hb1 Ac, Cortisol, Lipid Profile, Vitamin Profile.Timepoint: Same as primary outcome