Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children (PB-SAM)

niversity of Oxford0 个研究点目标入组 1,200 人开始时间: 2021年1月20日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Age =2 to <59 months
•Admitted to hospital with an acute, non-traumatic illness and within 72 hours of admission at the time of enrolment
•Severe malnutrition (weight-for-height <-3 z scores of the median WHO growth standards and/or mid upper arm circumference <115mm (<110mm age below 6 months), or symmetrical oedema of at least the feet related to malnutrition (not related to a primary cardiac or renal disorder)
•Presence of two or more features of severity as specified in the protocol and trial SOP. If a child meets two criteria, they may be enrolled before further criteria are assessed (e.g. a child may be eligible on clinical signs before the complete blood count results are known).
•Accompanied by care provider who provides written informed consent
•Primary caregiver plans to stay in the study area during the duration of the study.

•Requires immediate cardiac/respiratory resuscitation (may be re-evaluated for study eligibility within 72h of admission)
•Presence of terminal illness (other than severe acute malnutrition) likely to result in death within 6 months in the opinion of the recruitment team
•Known congenital heart disease
•Admission for traumatic or surgical indication
•Known liver disorder or exocrine pancreatic disorder – e.g. biliary atresia, history of gallstones, cystic fibrosis or clinical jaundice
•Known stomach or duodenal ulcer
•Residence is outside the catchment area of study hospital
•Primary caregiver declines to provide informed consent
•Known intolerance or allergy to any study medication

发起方