Intestinal adsorbent in childhood diarrhoea in Gambia

Enteromed Ltd0 个研究点目标入组 50 人开始时间: 2023年2月7日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Children aged 6 to 59 months with acute diarrhoea (3 or more loose or watery stools in 24 hours) for less than 4 days duration (to exclude episodes that are already resolving) and either no or some dehydration defined according to WHO Integrated Management of Childhood Illness criteria
•Written parent/guardian informed consent

•Diarrhoea lasting 4 or more days
•Severe dehydration according to WHO Integrated Management of Childhood Illness criteria
•Severe acute malnutrition defined as mid-upper arm circumference <11.5cms, weight-for-length/height z score <-3 and/or nutritional oedema (bilateral pedal oedema ascribed by the clinician to result from malnutrition).
•A suspected or confirmed significant concomitant illness such as malaria, sepsis or dysentery with systemic disturbance (e.g. toxicity; signs of peritonism)
•Suspected intestinal obstruction
•Use of anti-diarrhoeal medications, probiotic supplements or other intestinal adsorbents (e.g. activated charcoal, kaoline, diosmectite)
•Use of modified-release medications
•Use of any clinical trial investigational medication within the last 30 days before screening visit
•Any underlying condition that in the health professional’s or investigator’s opinion could affect the child’s participation in this study or the results of this study
•No access to a mobile phone or land line for follow-up at home

发起方

Enteromed Ltd