Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

NCT ID: NCT03061097

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2019-06-18

Brief Summary

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.

Detailed 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

Conditions

Antibiotic Resistant Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Treatment (autologous fecal microbiota preparation)

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

Group Type: EXPERIMENTAL

Autologous fecal microbiota transplant (Auto-FMP Enema)

Intervention Type: BIOLOGICAL

FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo Enema Preparation

Intervention Type: OTHER

The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.

Interventions

Autologous fecal microbiota transplant (Auto-FMP Enema)

FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.

Intervention Type: BIOLOGICAL

Placebo Enema Preparation

The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium

2. Adults (18 years or older)

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

Exclusion Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Microbiome Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Majdi Osman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Microbiome Health Research Institute, (d/b/a OpenBiome)

Locations

Boston University - Boston Medical Center nursing home consortium

Boston, Massachusetts, United States

Countries

United States

References

Liu CK, Seo J, Pravodelov V, Frazier S, Guy M, Concilio K, Lau-Ng R, Brandeis G, Watson J, van der Velde J, Olesen SW, Budree S, Njenga M, Kassam Z, Osman M. Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety. Contemp Clin Trials Commun. 2022 Mar 7;27:100906. doi: 10.1016/j.conctc.2022.100906. eCollection 2022 Jun.

Reference Type: DERIVED

PMID: 35299780 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

200201691946

Identifier Type: -

Identifier Source: org_study_id