drugset
drugset / Trial / NCT03298048

Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)

NCT03298048 ↗

Phase 2 Terminated 17 enrolled The University of Texas Health Science Center, Houston
RandomizedParallel-groupTriple-blindTreatment

Summary

To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection

Timeline

Start
2017-12-21
Primary completion
2019-03-30
Completion
2019-06-30

Outcome

Outcome not reported

Stopped: “Investigators are no longer considering FMT product development for C. difficile.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator PRIM-DJ2727 Other / unclassified 50 g Oral
Comparator PRIM-DJ2727 Other / unclassified 100 g Oral

Indications

Clostridium difficile colitis