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)

Phase II. 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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.

Conditions

• Recurrent C. Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	Low fecal microbiota dose	receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
BIOLOGICAL	Mid fecal microbiota dose	receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
BIOLOGICAL	High fecal microbiota dose	receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Timeline

• Start date: 2017-12-21
• Primary completion: 2019-03-30
• Completion: 2019-06-30
• First posted: 2017-09-29
• Last updated: 2020-03-06
• Results posted: 2020-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study