NCT04729790

Randomized Clinical Trial of Standard FMT Treatments

Phase II Randomized Clinical Trial of Standard FMT Treatments: Non-powered Pilot Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (RCDI) Using Either Single or Three Combined Products From Healthy Donors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). All subjects will be followed for approximately 180 days following FMT treatment for safety.

Detailed description

The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 days post FMT.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DRUG	PRIM-DJ2727	oral FMT capsules

Timeline

• Start date: 2020-01-10
• Primary completion: 2022-01-30
• Completion: 2022-04-30
• First posted: 2021-01-29
• Last updated: 2021-01-29

Regulatory

• FDA-regulated drug study