drugset / Trial / NCT02399618

Freeze-dried, Capsulized FMT for RCDI

NCT02399618

Phase 1 Unknown 20 enrolled Jinling Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.

Timeline

Start
2015-03
Primary completion
2016-09
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ornidazole Other / unclassified Oral