Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children

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.

Conditions

• SEPSIS
• MALNUTRITION, CHILD

Interventions

DRUG

Pancreatic Enzyme

CREON micro 5000

DRUG

Ursodeoxycholic acid

Ursodiol C24H40O4 suspension

OTHER

Pancreatic Enzyme placebo

Microcrystalline Cellulose,Macrogel 4000, Iron Oxide Yellow, Iron Oxide Red, Activated Charcoal.

OTHER

Ursodeoxycholic acid placebo

Sodium Citrate Dihydrate, Aspartame, Carboxymethylcellulose Sodium, Citric Acid Monohydrate, Dispersible Cellulose, Glycerol, Polysorbate-80, Saccharin Sodium,Sodium Benzoate, Sodium Methylparaben, Sodium Propylparaben

Sponsors & Collaborators

• University of Amsterdam

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• Queen Elizabeth Central Hospital, Blantyre, Malawi

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• KEMRI-Wellcome Trust Collaborative Research Program

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• James A Berkley, MD · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

2 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2023-10-31

Completion

2024-06-30

Countries

• Bangladesh
• Kenya
• Malawi
• Uganda

Study Locations