Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Propionibacterium freudenreichii P.UF1: One capsule once a day with/before breakfast for 120 days
Control Intervention1: Microcrystalline cellulose, calcium carbonate, Mg Stearate, Syly
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals ready to give voluntary, written informed consent to participate in the study. 2. Male and female teachers aged between 18 to 50 years (both values included) with moderate 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 4 to 6 episodes in a year). 5.Individuals who have active URTI episode at screening defined as those having a score of 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 and fiber supplements, probiotics, Echinacea, fish oil, vitamin E, etc.) at least 1 one month prior to screening. 8. Willing to discontinue sleep medications at least 1 month prior to screening and during the entire study duration. 9. Individuals willing to complete all study-related and clinical study visits as per the protocol.
Exclusion criteria
Exclusion criteria: 1.Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc 2. Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 month prior to screening. 3. Individuals with known sensitivity to the investigational products or any excipients of the 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 less than equal to 126 mg per dL. 8.Individuals with uncontrolled hypertension on medication and with systolic blood pressure 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 the participation 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 of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence. b) High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol 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 oral contraceptives. 17. Any condition that could, in the opinion of the investigator, preclude the individual s ability to successfully and safely complete the study or that may confound study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of the 120 days administration of ProGenr8 on % population having one or more episodes of URTI during the study duration as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire 21 (WURSS 21) as compared to baseline and placebo. Timepoint: Throughout the study during episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of ProGenr8 in comparison to baseline and placebo on: -Severity of the URTI episodes as assessed by WURSS 21. -Number of URTI episodes -Mean duration of URTI episodes as assessed by the time taken for resolution of the symptoms. -Number of missed work days due to URTI as assessed by e-diary records and attendance records. -Work productivity as assessed by WPAI. -Quality of life as assessed by WURSS-QoL.Timepoint: Throughout the study during episodes;To assess the effect of ProGenr8 in comparison to baseline and placebo on: -Satiety as assessed by Hunger Satiety Scale (HSS). - Mood as assessed by Brief Mood Introspection Scale (BMIS). -State anxiety and Trait anxiety as assessed by the State-Trait Anxiety Inventory (STAI). -Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI). -Working memory as assessed by Counting span task. -Stool consistency as assessed by Bristol Stool Form Scale (BSFS). -Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS). -Change in body weight assessed by weighing scale. -Anthropometric assessment as assessed by waist, hip, thigh circumference and waist to height ratio.Timepoint: Day 0, Day 30, Day 60, Day 90, Day 120];To assess the effect of ProGenr8 in comparison to baseline and placebo on -Body composition (Fat tissue, lean mass, fat free mass) as assessed by Dual Energy X-ray Absorptiometry (DEXA). -Gut microbiome analysis as assessed by Next Generation Sequencing (NGS). Timepoint: Day 0 and Day 120 | — |
Countries
India
Contacts
Public ContactDr Sonal Raote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed