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NOT YET RECRUITING
NCT07033754
NA

A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infection

Sponsor: Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

Propionibacterium freudenreichii P.UF1

one capsule once a day with/beforebreakfast for 120 days

DIETARY_SUPPLEMENT

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