NCT07033754

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

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• URTI - Viral Upper Respiratory Tract Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-25
• Primary completion: 2025-12-30
• Completion: 2026-01-20
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

6 sites across 1 country: India