Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization (RACE)

Microbiome Health Research Institute

Status and phase: Completed; Phase 1

Conditions: Antibiotic Resistant Strain

Treatments: Other: Placebo Enema Preparation; Biological: Autologous fecal microbiota transplant (Auto-FMP Enema)

Study type: Interventional

Funder types: Other

Identifiers

NCT03061097

200201691946

Details and patient eligibility

About

This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.

Full description

Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for study enrollment

1. Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium
2. Adults (18 years or older)

Inclusion criteria for randomization

1. Infection requiring antimicrobial treatment at the discretion of the treating physician

Exclusion criteria for study enrollment

1. Pregnant. Participants of childbearing age will undergo urine pregnancy testing
2. Participant or substitute decision maker unable to provide informed consent
3. Allergies to following ingredients generally recognized as safe: glycerol and sodium chloride
4. Current enrollment in hospice
5. Colostomy
6. Unable to adhere to protocol requirements
7. Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
8. Recent travel (last six months) to high risk regions based on the International SOS Medical Risk Rating system
9. Recent exposure (last six months) to unsafe drinking water

Exclusion criteria for stool collection

Enrollment stool sample will be tested for ARBs and processed into autologous FMT treatment (if of qualifying size). Sample will not be collected if any of the following are true:

1. Oral or intravenous antibiotic exposure within the previous 6 weeks of stool collection date (topical antibiotics will be permitted)
2. Active gastrointestinal infection at stool collection
3. Fever at the time of stool collection
4. Currently ill or complaining of any of the following signs or symptoms of illness: fever, diarrhea, blood stools and/or vomiting
5. Participants with a history of gastrointestinal (GI) illness within the past 30 days prior to enrollment stool collection, that at the discretion of the site investigator could reasonably be caused by one of the following pathogens: 1) Vibrio spp. 2) Norovirus 3) Rotovirus 4) Adenovirus 5) Shiga toxin

Exclusion criteria for randomization

• Colonized with CRE (assessed by PCR or culture assay during enrollment phase)
• Colonized with VRE (assessed by PCR or culture assay during enrollment phase)
• Colonized with ESBL (assessed by PCR or culture assay during enrollment phase)
• Colonized with CDI (assessed by EIA assay on stool collected at enrollment phase)
• Treatment with antibiotics which are active against MRSA (i.e. vancomycin or linezolid) prior to randomization to FMT intervention or placebo.
• Stool culture positive for common enteric pathogens (Salmonella spp., Shigella spp., Campylobacter spp.)
• Participants who develop a GI illness with symptoms such as (but not limited to) vomiting or diarrhea within 30 days after collection of enrollment stool will be evaluated by the site investigator. If the site investigator determines that the symptoms were most likely caused by 1) Vibrio spp., 2) Norovirus, 3) Rotavirus, 4) Adenovirus, or 5) Shiga toxin, the enrollment stool will be sent out to test for these organisms. If the culture is positive for any of these organisms, the participant will be excluded from randomization
• Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
• Participants who become severely immunocompromised, as defined by the investigator or treating physician, will be excluded prior to receiving intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups, including a placebo group

Treatment (autologous fecal microbiota preparation)

Experimental group

Description:

Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose

Treatment:

Biological: Autologous fecal microbiota transplant (Auto-FMP Enema)

Placebo

Placebo Comparator group

Description:

Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.

Treatment:

Other: Placebo Enema Preparation