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)

Recurrent C. Difficile Infection Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Clostridium Infections
• Communicable Diseases
• Infection
• Recurrent C. Difficile Infection

• NCT number: NCT03298048
• Study type: Interventional
• Source: The University of Texas Health Science Center, Houston
• Status: Terminated
• Phase: Phase 2
• Start date: December 21, 2017
• Completion date: June 30, 2019