Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

Completed

• Conditions: Clostridium Difficile Infection

• Registration Number: NCT02326636
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this research is to investigate the efficacy of transplanting screened donor fecal material in treating patients with recurrent Clostridium difficile infection. Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema and their response will be evaluated by symptom questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-26
• Study First Posted: 2014-12-29
• Primary Completion: 2018-10-26
• Study Completion: 2018-10-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The recurrence rate of Clostridium difficile 4 weeks after FMT.	Four weeks

Secondary Outcome Measures

Name	Time	Method
The rate of adverse events that may be related to FMT.	Up to 24 weeks
Satisfaction with the FMT procedure. ( satisfaction questionnaire )	Up to 24 weeks	Subjects will complete a satisfaction questionnaire following the FMT procedure.
Quality of life before and 4 weeks after FMT.	Four weeks	Subjects will complete a quality of life questionnaire before and 4 weeks after FMT.
Alternate treatments needed for Clostridium difficile before and after FMT.	Up to 24 weeks	Subjects medication and treatment history for Clostridium difficile before and after FMT will be collected.
Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.	Four weeks

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States