A Multicentre, Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilis HU58 + Bacillus coagulans SC208 Syrup in Treatment of Acute Diarrhoea in Children.

Synergia Life Sciences Pvt Ltd0 个研究点目标入组 64 人开始时间: 待定最近更新: 2022年10月17日

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•1. Male or Female subjects between Ã¢â?°Â¥1 to Ã¢â?°Â¤ 12years of age both inclusive.
•2. The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child will comply with the requirements of the protocol.
•3. Written informed consent /assent obtained from the parent(s)/LAR(s) of the subject and the subject respectively for participation in the study.
•1. Subjects undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.
•2. Subject suffering from Antibiotic-associated Diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period.
•1. Subject with clinical diagnosis of acute infective diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period and lasting for less than three days).

•1. History of pre-existing diarrhoea within the previous 4 weeks.
•2. Subjects requiring hospitalisation.
•3. Subjects with Severe dehydrationrequiring intravenous rehydration.
•4. Subjects with bloody and/or purulent stools
•5. Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, CrohnÃ¢â?¬Ë?s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhoea and functional constipation.
•6. Subjects with gastrointestinal surgery.
•7. History of severe chronic systemic diseases, critical/life-threatening illness or immunodeficiency diseases.
•8. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo.
•9. Use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic 14 days before and during the study
•10. Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study.
•11. Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.

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