ClinicalTrials.gg
Not yet recruitingNCT07033754Updated Jun 24, 2025

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

An interventional study of Propionibacterium freudenreichii P.UF1 and Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia in URTI - Viral Upper Respiratory Tract Infection, sponsored by Vedic Lifesciences Pvt. Ltd.. Not yet recruiting at 6 sites in India. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • URTI - Viral Upper Respiratory Tract Infection
03

In context

Lead sponsor

Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 72 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals ready to give voluntary, written 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 (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

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 products or any ofthe product.
  4. Individuals with any 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, ,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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Propionibacterium freudenreichii P.UF1

    one capsule once a day with/beforebreakfast for 120 days

    Dietary Supplement: Propionibacterium freudenreichii P.UF1

  • Placebo comparator
    Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia

    one capsule once a day with/beforebreakfast for 120 days

    Dietary Supplement: Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia

Interventions

  • Dietary supplementPropionibacterium freudenreichii P.UF1

    one capsule once a day with/beforebreakfast for 120 days

  • Dietary supplementMicrocrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia

    one capsule once a day with/beforebreakfast for 120 days

06

What researchers measure

Primary outcomes

  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.

    The WURSS-21 includes nine items assessing the impact of the URTI episode on an individual's quality of life i.e., the ability to think clearly, sleep well, breathe easily, exercise, work inside and outside the home, accomplish daily activities, interact with others and live one's personal life. All the items will be scored on an 8-point Likert scale ranging from 0 which depicts "absent or no impairment" to 1 (very mild), 3 (mild) 5(moderate), and 7 (severe). Participants will be instructed to fill this questionnaire whenever they have a URTI episode on all days throughout the study. An average of all WURSS-21 QoL scores will be calculated for every episode and considered to analyze the change in QoL as compared to baseline and placebo.

    Time frame: Day 30,Day 90 & Day 120

Secondary outcomes

  1. To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire(WURSS-21)

    In WURSS-21 All the items will be scored on an 8-point Likert scale ranging from 0, which depicts "absent or no impairment", to 1 (very mild), 3 (mild), 5 (moderate), and 7 (severe).43 The global score of WURSS-21 (question no. 1-19) ranges from 0-133 per day. Higher scores represent higher severity

    Time frame: From Date of Randomization upto 120 days

  2. To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Number of URTI episodes

    the number of URTI episodes (frequency) and proves to be beneficial in individuals suffering from frequent URTI episodes

    Time frame: From Date of Randomization upto 120 days

  3. To Measure the effect of IP in comparison to baseline and placebo on -Body composition (Fat tissue, lean mass, fat free mass) as assessedby Dual Energy X-ray Absorptiometry -Gut microbiome analysis as assessed by Next Generation Sequencing

    Dual Energy X-ray Absorptiometry Scans can assess fat content and total body composition with a high degree of precision that is comparable to hydrostatic weighing The investigation of the gut microbiota in a culture-independent manner has been made possible by next-generation sequencing technology, which has provided insights into the intricate and little-understood interactions between the gut microbiome and its host

    Time frame: Day 0 and Day 120

07

Study locations

6 sites
  • Nand Hospital
    Vadodara, Gujarat 390007, India
  • Lifeline Clinicand Diagnostics
    Nashik, Maharashtra 422010, India
  • AMF MorayaMultispecialityHospital
    Pune, Maharashtra 411033, India
  • ENT and VertigoClinic
    Pune, Maharashtra 411045, India
  • Madhumeh Clinic
    New Delhi, National Capital Territory of Delhi 110091, India
  • Janta Hospital &MaternityCentre
    Varanasi, Uttar Pradesh 221011, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07033754
Responsible party
Sponsor
First posted
Jun 24, 2025
Start date
Jun 25, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Jan 20, 2026 (estimated)
Last update
Jun 24, 2025

Study contacts

Dr Sanjay Vaze, MBBS
Contact
sanjay.v@vediclifesciences.com
8655670964
Dr Sonal Raote, BAMS
Contact
sonal.raote@vediclifesciences.com
7738373850

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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