FMT for Multidrug Resistant Organism Reversal

NCT ID: NCT02312986

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-07-31

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.

Conditions

Infection With Multi-drug Resistant Organisms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal microbiota transplantation

Subjects will receive 150mL of fecal microbiota product via enema.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation (FMT)

Intervention Type: BIOLOGICAL

Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.

Interventions

Fecal microbiota transplantation (FMT)

Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.

Intervention Type: BIOLOGICAL

Other Intervention Names

FMT; stool transplant

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years old.
• Outpatient status at time of FMT.
• History of at least three recurrent infections due to an 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 (see above) are available AND the MDRO is likely of enteric origin. Only MDROs of likely enteric origin will be included.
• Be without active infection due to the MDRO at the time of FMT.
• Not be receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT.

Exclusion Criteria

• Subjects <18 years old.
• Subjects unable to be seen as an outpatient.
• Use of enteral or systemic antimicrobials at time of FMT.
• Planned use of enteral or systemic antimicrobials up to 6 months post-FMT.
• Pregnancy or inability/unwillingness to use contraceptives.
• Recent intra-abdominal surgery
• Short gut syndrome
• Gastrointestinal motility disorders
• Use of medications that affect intestinal motility an inability to cease using those medications at the time of FMT.
• Post-allogeneic hematopoietic stem cell transplant recipients with previous or current gastrointestinal graft versus host disease.
• ANC <500/mm3
• HIV+ and not well controlled on antiretroviral therapy, or CD4+ <200/ mm3
• At increased risk for peritonitis: presence of intra-abdominal devices, receiving peritoneal dialysis, or ascites.
• Any acute illness
• Recurrent C. difficile infection.
• Unlikely to survive for 3 months.
• Investigator feels the risks of FMT outweigh potential benefit, including other conditions or medications that the investigator determines puts the subject at greater risk from FMT.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik R Dubberke, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201506131

Identifier Type: -

Identifier Source: org_study_id