A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Res… (NCT07033754) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infection
India100 participantsStarted 2025-06-25
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. Individuals who have active URTI episode at screening defined as "those having a scoreof less than equal to 5 for at least 2 symptoms out of runny nose, plugged nose,sneezing, sore throat, scratchy throat, cough or head congestion on the WURSS-21".
. Commitment to adhere to routine diet and physical activity.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Measure the effect of the 120 days' administration of IP on %population having one or more episodes of URTI during the study duration asassessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire as compared to baseline and placebo.
. Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics andfiber supplements, probiotics, Echinacea, fish oil, vitamin E, etc.) at least 1 one monthprior to screening.
. Willing to discontinue sleep medications at least 1 month prior to screening and duringthe entire study duration.
Exclusion criteria
. 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.).
. Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
. Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, and vapor rub, etc.
. Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose lessthan equal to 126 mg per dL.
. Individuals with uncontrolled hypertension on medication and with systolic bloodpressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.