A double blind, multicenter, randomized, parallel group, comparative post marketing surveillance study to evaluate the efficacy and safety of S. boulardii (strain CNCM I-3799) (LesunBerry) plus standard treatment (containing ORS and Zinc) in comparison with standard treatment alone in acute childhood diarrhoea.

Investigator initiated trial0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•(1) Male and,or female children of age 3 months to 36 months (both inclusive) with acute diarrhoea.
•(2) Child having three or more loose stools in last 24 hrs.
•(3) Subjects parent(s) or legal guardian are willing to provide informed consent form and also willing to comply with all the study requirements.

•-Dysentery (presence of visible blood in stools)
•-Clinical evidence of coexisting any acute systemic illness (for e.g. meningitis, sepsis, pneumonia)
•-Clinical evidence of chronic disease (for e.g. chronic liver disease, chronic renal disease, nephrotic syndrome)
•-Known case of chronic gastrointestinal disease like celiac disease or inflammatory bowel disease
•-Use of probiotics in previous week
•-Use of antibiotics or an other anti-diarrhoeal medication for the current episode of diarrhoea in previous week.
•-Invasive diarrhoea
•-Clinical evidence of severe malnutrition based on weight-for-Length less than 3 SD of WHO Reference Card
•-Severe dehydration (shock with diminished consciousness, lack of urine output, cool, moist extremities, a rapid and feeble pulse, low or undetectable blood pressure and pale skin)
•-Participation in any other clinical study during last 30 days
•-Children with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

发起方

Investigator initiated trial