NCT02399618

Freeze-dried, Capsulized FMT for RCDI

Freeze-dried, Capsulized Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2015-03-26
• Last updated: 2016-05-25

Locations

1 site across 1 country: China