Propionibacterium freudenreichii P.UF1
Dietary Supplementone capsule once a day with/beforebreakfast for 120 days
NCT Number: NCT07033754
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Not applicable
Nand Hospital, Vadodara, Gujarat, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
one capsule once a day with/beforebreakfast for 120 days
one capsule once a day with/beforebreakfast for 120 days
Time frame: Day 30,Day 90 & Day 120
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: From Date of Randomization upto 120 days
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
the number of URTI episodes (frequency) and proves to be beneficial in individuals suffering from frequent URTI episodes
Time frame: Day 0 and Day 120
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
Contact information is provided by the study sponsor or research team.
Dr Sanjay Vaze, MBBS
CONTACT
Dr Sonal Raote, BAMS
CONTACT
Vedic Lifesciences Pvt. Ltd.
Industry
A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of ProGenr8™ (Probiotic Supplement) on Immune Health in Teachers Prone to Upper Respiratory Tract Infection (URTI)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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