A Prospective, Open label, Randomized, Comparative, Multicentric Study to Evaluate Efficacy and Safety of Streptococcus salivarius K12 Probiotic in Children with Recurrent URTI.

Dr Reddy’s Laboratories Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1.Children aged 3-6 years (male and female subjects) at the enrolment.
•2.Children with symptoms/history of recurrent URTI/acute otitis media, and repeated episodes of common cold or flu.
•3.Children who experienced 3 or more episodes of any upper respiratory tract infections viz streptococcal infection, viral infection etc. within 1 year from screening.
•4.Children with no flu vaccination.
•5.Children/Children’s parent who are willing to avoid any other probiotic supplements or dairy probiotic products (probiotic yoghurt, acidophilus milk, kefir etc.) for the duration of the study.
•6.Parents/LAR who are able to understand written instructions and are ready to comply with all study requirements with a willingness to participate their child and give written informed consent voluntarily.

•1.Children suffering from pneumonia or bronchiolitis at the time of screening.
•2.Children who had underwent tonsillectomy or adenoidectomy.
•3.Children with known significant systemic disease (i.e, hepatic and or renal disease), malignant disease, autoimmune disease, other systemic diseases related to immune system disorders and diseases of the gastrointestinal tract which would impair absorption of the study medication.
•4.Children treated with the following medications: Antibiotics within one week before enrolment in the study, oral vaccination with live vaccine within 4 weeks before enrolment in the study, previous and/or concomitant immunosuppressive or immuno stimulating therapy including (vitamin –C, zinc, pidotimod, etc.) within 3 months before enrolment in the study.
•5.Participation in another clinical trial within 3 months prior to enrolment in the study.

发起方

Dr Reddy’s Laboratories Ltd