Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children
Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
Children with severe malnutrition who are sick and admitted to hospitals have high mortality,
usually because of infection. Malnourished children have more potentially harmful bacteria in
their upper intestines than well-nourished children and this may contribute to inflammation
in the gut and whole body. These bacteria may cross from the intestines to the bloodstream
causing life-threatening infections. A related abnormality among malnourished children is
reduction in the digestive enzymes made by the pancreas and the liver. Apart from helping
with digestion of food, these enzymes are important in helping the body control bacteria in
the upper intestines. It is therefore possible that treatment with digestive enzymes could
help reduce the burden of harmful bacteria and thus lower inflammation and the risk of
serious infection. One study conducted in Malawi has shown that children with severe
malnutrition who were supplemented with pancreatic enzymes had a lower risk of dying.
However, this was a small study and although promising, requires validation. No studies of
supplementation with bile acids have been done among severely malnourished children. However,
bile acids are commonly used to manage patients with liver function abnormalities, something
that malnourished children suffer from as well. The investigators want to find out if
supplementing these pancreatic enzymes and bile acids among ill children with severe acute
malnutrition is safe and reduces the risk of death, deterioration or readmission to hospital.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh KEMRI-Wellcome Trust Collaborative Research Program Kenya Medical Research Institute Makerere University Oregon Health and Science University Queen Elizabeth Central Hospital, Blantyre, Malawi University of Amsterdam University of Toronto University of Washington