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

Launched by VEDIC LIFESCIENCES PVT. LTD. · Jun 19, 2025

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ClinConnect Summary

This clinical trial is studying whether taking a probiotic supplement can help improve the immune health of teachers who often get viral upper respiratory tract infections (like common colds). The goal is to see if the probiotic can reduce how often and how severely these infections occur. The study plans to include about 144 teachers aged 18 to 50 who have had frequent colds—at least 4 to 6 times in the past year—and are generally active and within a certain healthy weight range.

If you join the study, you would be randomly assigned to take either the probiotic or a placebo (a pill with no active ingredient) every day for about four months. Neither you nor the researchers will know which one you’re taking until the study ends. You’ll need to stick to your usual diet and exercise habits and avoid other supplements or medications that might affect your immune system during this time. The study will include regular check-ins to monitor your health and symptoms. This trial is not yet recruiting participants, but if you meet the criteria and are interested, it could be a way to help find new ways to support immune health in people who frequently catch colds.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Individuals ready to give voluntary, written informed consent to participate in thestudy.
• • 2. 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).
• • 3. Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2
• • 4. High susceptibility to URTIs at least once every three months for last 1 year (at least 4to 6 episodes in a year).
• • 5. 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".
• • 6. Commitment to adhere to routine diet and physical activity.
• • 7. 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.
• • 8. Willing to discontinue sleep medications at least 1 month prior to screening and duringthe entire study duration.
• • 9. Individuals willing to complete all study-related and clinical study visits as per theprotocol.
• Exclusion Criteria:
• • 1. Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction ordeformity, nasal reconstructive surgery, etc
• • 2. Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 monthprior to screening.
• • 3. Individuals with known sensitivity to the investigational products or any excipients ofthe product.
• • 4. Individuals with any clinically significant abnormalities of the upper respiratory tract(such as stridor, laryngomalacia, etc.).
• • 5. Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
• • 6. 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.
• • 7. Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose lessthan equal to 126 mg per dL.
• • 8. Individuals with uncontrolled hypertension on medication and with systolic bloodpressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.
• • 9. Individuals who are unable to abstain from herbal or dietary supplements for URTI throughout the study period.
• • 10. Vaccination against influenza or swine flu within 90 days prior to screening.
• • 11. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids,nasal decongestants, antihistamines, NSAIDs, or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.
• • 12. History of any significant neurological and psychiatric condition which may affect theparticipation and inference of the study's end points.
• • 13. Participation in other clinical trials in last 90 days prior to screening
• • 14. Individuals with substance abuse problems (within 2 years) defined as: a) Use ofrecreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobaccoor smoking dependence. b) High-risk drinking as defined by consumption of 4 or morealcohol containing beverages on any day or 8 or more alcohol containing beverages perweek for women and 5 or more alcohol-containing beverages on any day or 15 or morealcohol containing beverages per week for men.
• • 15. Individuals who have clinically significant following severe illness
• • 16. Females who are pregnant/planning to be pregnant or lactating or taking any oralcontraceptives.
• • 17. Any condition that could, in the opinion of the investigator, preclude the individual'sability to successfully and safely complete the study or that may confound studyoutcomes