Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

October 31, 2023

Study Completion Date

June 30, 2024

Conditions
SEPSISMALNUTRITION, 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

Trial Locations (4)

80800

KEMRI WT Clinical Trials Facility, Kilifi

Unknown

ICDDR,B Dhaka Hospital, Dhaka

Queen Elizabeth Central Hospital, Blantyre

Mulago Hospital, Kampala

Sponsors
All Listed Sponsors
collaborator

University of Amsterdam

OTHER

collaborator

University of Toronto

OTHER

collaborator

University of Washington

OTHER

collaborator

Oregon Health and Science University

OTHER

collaborator

Kenya Medical Research Institute

OTHER

collaborator

Queen Elizabeth Central Hospital, Blantyre, Malawi

UNKNOWN

collaborator

Makerere University

OTHER

collaborator

KEMRI-Wellcome Trust Collaborative Research Program

OTHER

collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

lead

University of Oxford

OTHER