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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorVedic Lifesciences Pvt. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Individuals ready to give voluntary, written informed consent to participate in thestudy.

Male and female teachers aged between 18 to 50 years' (both values included) withmoderate physical activity level as per International Physical Activity Questionnaire -Short Form (IPAQ - SF).

Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2

High susceptibility to URTIs at least once every three months for last 1 year (at least 4to 6 episodes in a year).

Disqualifiers

Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction ordeformity, nasal reconstructive surgery, etc

Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 monthprior to screening.

Individuals with known sensitivity to the investigational products or any excipients ofthe product.

Individuals with any clinically significant abnormalities of the upper respiratory tract(such as stridor, laryngomalacia, etc.).

Trial design

Treatments tested in this trial

  • Propionibacterium freudenreichii P.UF1
  • Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators