A Prospective, Interventional, Randomized, Double blind and Placebo Control Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii UBBC07 suspension in the Treatment and prevention of Upper Respiratory Tract Infections in Pediatric age group.

nique Biotech Ltd0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Diagnostic Criteria:
•Suffering from URTI i.e. at least 6 URTIs episodes medically confirmed, with a maximum of 18, during the 1 Year before the study.
•2.Ethical or legal considerations:
•Children whose parents or guardians of the children who are willing to give written informed consent or AV recording as per the regulatory requirement
•3.Informed consent with AV recording by study participants

•1.Patient suffering from pneumonia or bronchiolitis at the time of enrolment visit
•2. Patients who had underwent tonsillectomy or adenoidectomy
•3.Patient with known significant systemic disease, i.e. hepatic and or renal disease
•4.Patient with malignant disease
•5.Patient with autoimmune disease and other systemic diseases related to immune system disorders
•6.Patient with diseases of the gastrointestinal tract which would impair absorption of the study medication
•7.Patient treated with the following medications:
•Antibiotics within one week before study start oral vaccination with live vaccine within 4 weeks before study start previous and/or concomitant immunosuppressive or immuno stimulating therapy within 3 months before study start.
•8.concomitant treatment with corticosteroids
•9.concomitant treatment with an investigational drug within 1 month before study start
•10.Participation in another clinical trial within 3 months prior to study start

发起方

nique Biotech Ltd