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

Официальное название

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)

Обзор

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.

Вмешательства

• Пищевая добавка Propionibacterium freudenreichii P.UF1
  one capsule once a day with/beforebreakfast for 120 days
• Пищевая добавка Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia
  one capsule once a day with/beforebreakfast for 120 days

Первичные конечные точки

• 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. [Срок оценки: Day 30,Day 90 & Day 120]

Вторичные конечные точки (3)

• 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) [Срок оценки: From Date of Randomization upto 120 days]
• 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 [Срок оценки: From Date of Randomization upto 120 days]
• 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 [Срок оценки: Day 0 and Day 120]

Критерии участия

Критерии включения

• 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 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".
• Commitment to adhere to routine diet and physical activity.
• 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.
• Willing to discontinue sleep medications at least 1 month prior to screening and duringthe entire study duration.
• Individuals willing to complete all study-related and clinical study visits as per theprotocol.

Критерии исключения

• 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.).
• Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
• 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.
• Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose lessthan equal to 126 mg per dL.
• Individuals with uncontrolled hypertension on medication and with systolic bloodpressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.
• Individuals who are unable to abstain from herbal or dietary supplements for URTI throughout the study period.
• Vaccination against influenza or swine flu within 90 days prior to screening.
• 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.
• History of any significant neurological and psychiatric condition which may affect theparticipation and inference of the study's end points.
• Participation in other clinical trials in last 90 days prior to screening
• 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.
• Individuals who have clinically significant following severe illness
• Females who are pregnant/planning to be pregnant or lactating or taking any oralcontraceptives.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Индия · 6 центров

• Nand Hospital — Vadodara
• Lifeline Clinicand Diagnostics — Nashik
• AMF MorayaMultispecialityHospital — Pune
• ENT and VertigoClinic — Pune
• Madhumeh Clinic — New Delhi
• Janta Hospital &MaternityCentre — Varanasi

Идентификаторы

NCT: NCT07033754 · SB/240701/IP/URTI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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