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

Phase 2

• Conditions: Digestive System; Acute infectious diarrhoea

• Registration Number: PACTR202302683128875
• Lead Sponsor: Enteromed Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-07
• Last Update Posted: 29 May 2023

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

Primary Outcome Measures

Name	Time	Method
Duration of diarrhoea defined as time (hours) from randomisation to last watery stool (takes the shape of the container)

Secondary Outcome Measures

Name	Time	Method
•Hydration status at 4 hours (end of blinded phase) according to clinical assessment based on WHO IMCI criteria and change in weight from 0 to 4 hours<br>•Volume of ORF / ORF + Enterosgel® taken<br>•Requirement for naso-gastric tube fluids<br>•Evolution to severe disease defined as requirement for intravenous (IV) fluids or hospital admission after starting treatment (e.g. because of persistent vomiting; worsening dehydration)<br>•Duration of diarrhoea defined as time (hours) from randomisation to first non-watery stool (has its own form)<br>•Percentage of patients with diarrhoea that has resolved on days 3 and day 5<br>•Vomiting<br>•Abdominal pain<br>•Vesikari score calculated for the illness (up to a maximum of 5 days)<br>•Safety including measurement of serum electrolytes in blood samples collected at baseline and 4 hours<br>•Adverse events<br>