FMT for Multidrug Resistant Organism Reversal

NCT02312986 | Completed Phase 1 Results

• 1 other identifier: 201506131
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection With Multi-drug Resistant Organisms

Keywords

infection; colonization; antibiotic resistance

Outcome Measures

Primary Outcomes (1)

• Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events)

  Incidence and severity of solicited and serious adverse events within 12 months of FMT.

  12 months post-FMT

Secondary Outcomes (1)

• MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections)

  30 days, 6 months, and 12 months post-FMT

Study Arms (1)

Fecal microbiota transplantation

EXPERIMENTAL

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

Biological: Fecal microbiota transplantation (FMT)

Interventions

Fecal microbiota transplantation (FMT) BIOLOGICAL

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

Also known as: FMT, stool transplant

Fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Infections

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Kimberly Reske, MPH, Research Coordinator
• Organization: Washington University in St. Louis

kreske@wustl.edu

314-747-4041

Study Officials

• Erik R Dubberke, MD, MSPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 9, 2014
• Study Start: August 1, 2015
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 24, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02