PB-SAM: Pancreatic Enzymes and Bile Acids Trial
Testing whether pancreatic enzymes and bile-acid treatment improve outcomes in hospitalised children with severe acute malnutrition.
Why this research began
Severe malnutrition can involve impaired pancreatic and hepatobiliary function, intestinal dysbiosis and inflammation.
What the study asks
Can pancreatic enzymes or ursodeoxycholic acid reduce mortality or improve recovery?
How the research works
Randomized, double-blind, placebo-controlled 2×2 factorial trial. Outcomes included 60-day mortality, safety, diarrhoea, antibiotic use, hospital stay and anthropometric recovery.
Who contributes
The reported trial enrolled 429 children across participating sites.
Where it takes place
Multicentre research including Malawi and collaborating countries.
Study objectives
Test pancreatic enzyme replacement.
Test ursodeoxycholic acid treatment.
Evaluate mortality, safety and nutritional recovery.
Principal and contributing research team
Status and study timeline
- 01Protocol and site preparation
- 02Multicentre enrolment
- 0360-day follow-up
- 04Analysis and reporting
Participating and collaborating institutions
Publications and findings
task_altThe reported preprint found no reduction in 60-day mortality from the evaluated interventions.
task_altNeutral results help prevent adoption of ineffective treatment and inform future priorities.
Pancreatic enzymes and/or bile acids for acutely ill severely malnourished children: a double-blind randomized placebo-controlled trial
Bandsma, R.H.J.; Chisti, M.J.; Voskuijl, W.P.; et al. — Preprint
Related news, documents and contact
Related updates
No related public updates have been published yet.
Study documents
Approved protocols, public summaries and shareable study materials are published through the research resources library.
Browse research resources arrow_forwardResearch contact
Contact MNRG for collaboration, study information or approved document requests.
Contact the research team arrow_forwardWhy it matters
The preprint reported no mortality reduction. Neutral results prevent ineffective interventions from being adopted and refine future priorities.