Digestive System Acute infectious diarrhoea
Conditions
Interventions
Standard treatment oral rehydration fluid and oral zinc
Enterosgel
Sponsors
Enteromed Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of diarrhoea defined as time (hours) from randomisation to last watery stool (takes the shape of the container) | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 • Volume of ORF / ORF + Enterosgel® taken • Requirement for naso-gastric tube fluids • 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) • Duration of diarrhoea defined as time (hours) from randomisation to first non-watery stool (has its own form) • Percentage of patients with diarrhoea that has resolved on days 3 and day 5 • Vomiting • Abdominal pain • Vesikari score calculated for the illness (up to a maximum of 5 days) • Safety including measurement of serum electrolytes in blood samples collected at baseline and 4 hours • Adverse events | — |
Countries
Gambia
Contacts
Public ContactStephen Allen
Consultant Paediatrician
Outcome results
None listed