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

NCT04371653 ↗

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

EvaluationDrugModalityDoseRoute
Subject PRIM-DJ2727 Other / unclassified — Oral