A randomized, double blind, placebo controlled, Three arm study to evaluate the efficacy & safety of probiotics – different Bacillus clausii strains in the prevention of Antibiotic Associated Diarrhea (AAD) in infants and children. - NI

Sanzyme Biologics P 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

研究概览

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•Mild to moderate infection of the respiratory, genito-urinary or skin and soft tissue admitted or consulted at the out patient for treatment of bacterial infection requiring Beta lactam antibiotic treatment for 5 to 14 days.

•1.Clinically unstable infants and children
•2.Subjects with critical illness, chronic diseases of the endocrine, cardiovascular, renal, or respiratory system (or any other clinically significant condition that might jeopardize a patient’s condition or study outcomes in the view of the Investigator),
•3.a history of or current presence of conditions known to produce immunodeficiency (congenital or acquired immunodeficiency syndromes, immunosuppressant therapy),
•4.presence of an in-dwelling vascular access line, a history of or current pancreatitis, history of abdominal surgery, bilious emesis, or
•5.participation in another clinical trial within the past 3 months.
•6.hypersensitivity to B. clausii or excipients in the investigational medical product or to other probiotics.
•7.long-term use of oral or intravenous corticosteroids within 6 months of enrollment.

发起方

Sanzyme Biologics P Ltd