FMT for Multidrug Resistant Organism Reversal

Phase 1

Completed

• Conditions: Infection With Multi-drug Resistant Organisms
• Interventions: Biological: Fecal microbiota transplantation (FMT)

• Registration Number: NCT02312986
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of likely enteric origin.

FMT will be performed on subjects with a history of at least three recurrent infections due to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities are available.

The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will be able to prevent additional recurrences of infections due to MDRO by suppressing or reversing enteric colonization with MDRO.

Detailed Description

This is a prospective pilot study of fecal microbiota transplantation in patients with a history of recurrent MDRO infections. Subjects who meet inclusion/exclusion criteria and provide written, informed consent will provide a pre-FMT stool sample. The FMT will be administered by enema in the outpatient setting by trained personnel. Patients will provide stool samples 30 days, 6 months, and 12 months post-FMT. The subjects will also be monitored for potential adverse events, recurrence of MDRO infections, infections that may be related to FMT, and worsening of existing comorbidities or development of new comorbidities.

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-09
• Study Start: 2015-08
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Results First Submitted: 2020-09-18
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal microbiota transplantation	Fecal microbiota transplantation (FMT)	Subjects will receive 150mL of fecal microbiota product via enema.

Primary Outcome Measures

Name	Time	Method
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events)	12 months post-FMT	Incidence and severity of solicited and serious adverse events within 12 months of FMT.

Secondary Outcome Measures

Name	Time	Method
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections)	30 days, 6 months, and 12 months post-FMT	Number of subjects with MDRO infections 30 days, 6 months, and 12 months post-FMT.