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A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infection
Sponsor: Vedic Lifesciences Pvt. Ltd.
Summary
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical studydesigned to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%,approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active orplacebo. The study will have at least 100 completed participants i.e. 50 participants in each studyarm after accounting for a dropout/withdrawal rate of 30% at the end of the study. The interventionand follow-up duration for all the study participants will be 120 days.
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of ProGenr8™ (Probiotic Supplement) on Immune Health in Teachers Prone to Upper Respiratory Tract Infection (URTI)
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-06-25
Completion Date
2026-01-20
Last Updated
2025-06-24
Healthy Volunteers
No
Interventions
Propionibacterium freudenreichii P.UF1
one capsule once a day with/beforebreakfast for 120 days
Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia
one capsule once a day with/beforebreakfast for 120 days
Locations (6)
Nand Hospital
Vadodara, Gujarat, India
Lifeline Clinicand Diagnostics
Nashik, Maharashtra, India
AMF MorayaMultispecialityHospital
Pune, Maharashtra, India
ENT and VertigoClinic
Pune, Maharashtra, India
Madhumeh Clinic
New Delhi, National Capital Territory of Delhi, India
Janta Hospital &MaternityCentre
Varanasi, Uttar Pradesh, India