A feasibility study of an intestinal adsorbent in childhood diarrhoea in The Gambia (INTAGAM)

Phase 2

Not yet recruiting

• Conditions: Digestive System; Acute infectious diarrhoea

• Registration Number: PACTR202302683128875
• Lead Sponsor: Enteromed Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-07
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified