Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

NCT03061097 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 200201691946
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Resistant Strain

Keywords

Autologous Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization

  Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.

  Day 7 after randomization

Secondary Outcomes (3)

• Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)

  Day 28 after randomization

• Number of Participants Who Develop Any ARB-associated Infections

  Day 3, Day 7, Day 28, Month 6

• Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6

  Day 28, Month 6

Other Outcomes (1)

• Microbiome Disruption Indices (MDI) (16S rRNA Sequencing)

  Day 0, Day 3, Day 7, Day 28

Study Arms (2)

Treatment (autologous fecal microbiota preparation)

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo Enema Preparation

Interventions

Autologous fecal microbiota transplant (Auto-FMP Enema) 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.

Treatment (autologous fecal microbiota preparation)

Placebo Enema Preparation OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium
• Adults (18 years or older)
• \) Infection requiring antimicrobial treatment at the discretion of the treating physician

You may not qualify if:

• Pregnant. Participants of childbearing age will undergo urine pregnancy testing
• Participant or substitute decision maker unable to provide informed consent
• Allergies to following ingredients generally recognized as safe: glycerol and sodium chloride
• Current enrollment in hospice
• Colostomy
• Unable to adhere to protocol requirements
• 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
• Recent travel (last six months) to high risk regions based on the International SOS Medical Risk Rating system
• 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:
• Oral or intravenous antibiotic exposure within the previous 6 weeks of stool collection date (topical antibiotics will be permitted)
• Active gastrointestinal infection at stool collection
• Fever at the time of stool collection
• Currently ill or complaining of any of the following signs or symptoms of illness: fever, diarrhea, blood stools and/or vomiting
• 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

Sponsors & Collaborators

• Microbiome Health Research Institute: lead
• Boston Medical Center: collaborator

Study Sites (1)

Boston University - Boston Medical Center nursing home consortium

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 35299780 DERIVED

Results Point of Contact

• Title: Majdi Osman, MD, MPH
• Organization: Microbiome Health Research Institute

majdi@openbiome.org

617-575-2201

Study Officials

• Majdi Osman, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: July 10, 2017
• Primary Completion: December 19, 2018
• Study Completion: June 18, 2019
• Last Updated: May 5, 2021
• Results First Posted: December 7, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)