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.
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 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.).
Parallel
Propionibacterium freudenreichii P.UF1
Dietary supplementone capsule once a day with/beforebreakfast for 120 days
Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia
Dietary supplementone capsule once a day with/beforebreakfast for 120 days
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.
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
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
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
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