drugset / Trial / NCT06461208
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Phase 3
Recruiting
300 enrolled
King's College London
BRITISH LIVER TRUST · collabGuy's and St Thomas' NHS Foundation Trust · collabImperial College London · collabKing's College Hospital NHS Trust · collabSt George's Healthcare NHS Trust · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.
Timeline
- Start
- 2023-06-21
- Primary completion
- 2028-01-31
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | faecal microbiota transplantation | Other / unclassified | 5 unknown | — |