drugset / Trial / NCT04371653
A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .
Timeline
- Start
- 2023-12-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
Outcome
Outcome not reported
Stopped (Business): “lack of funds”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRIM-DJ2727 | Other / unclassified | — | Oral |