Role of Saccromyces Boullardi CNCMI 745 in prevention of antibiotic associated gut dysbiosis in 3 to 6 year old children double blinded placebo controlled clinical trial

Dr Rachita Sewara0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•The present Double-blind, randomised, placebo-controlled clinical trial will be carried out after approval by the ethics committee of Dr. S. N. Medical College, Jodhpur and subjects will enrolled after written informed consent.
•Children attending Paediatric clinic of or are admitted in the paediatrics wards of UMAID /MDM hospital Jodhpur (Rajasthan) and who are prescribed Antibiotics for respiratory illness and otitis media will be recruited for the current study.

•children having any clinical evidence of:
•1. Known chronic or recurrent systemic disorder associated with immunocompromised.
•2. A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer’s or baker’s yeast, Amoxicillin-Clavulanate, amoxicillin or other penicillins, or cephalosporins.
•3. Prior gastrointestinal surgery.
•4. Known and diagnosed cases of Celiac disease.
•5. Diagnosed case of Cystic fibrosis.
•6. Structural GI diseases include strictures, stenosis, hemorrhoids, diverticular disease, colon polyps, colon cancer and inflammatory bowel disease.
•7. Oral or systemic antibacterial therapy during the 3 months prior to study enrolment.
•8. Prescription, over-the-counter medications or supplements that are known to alter gut function or microflora (i.e., acid anti-secretory drugs, probiotics) during the 4 weeks prior to study enrolment.
•9. Chronic or persistent diarrhoea (12 weeks) or severe diarrhoea, i.e. diarrhoea managed with intravenous fluids or requiring hospital admission.

发起方

Dr Rachita Sewara