Trial on pro-biotic health supplement for high altitude areas

Study of human microbiome and probiotic supplementation under extreme environmental conditions.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045812

Enrollment

1000

Registered

2022-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotic composition: Sorbitol, Xylitol, Maltodextrine, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii, Bacillus coagulans at a dos

Eligibility

Inclusion criteria

Inclusion criteria: BMI: 18-27 No antibiotic treatment in last 3 months No history of gastro-intestinal disease Maintenance of oral hygiene

Exclusion criteria

Exclusion criteria: Subjects with pre-existing clinically identified digestive and GI tract disease including Chrones. History of Bariatric surgery or intestinal injury

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Dipti Prasad

Defence Institute of Physiology and Allied Sciences

rcmeena.dipas@gov.in

Outcome results