Clinical trial NCT03061097: Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization
Official title: Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Antibiotic Resistant Strain
Keywords: Autologous Fecal Microbiota Transplantation
Lead sponsor: Microbiome Health Research Institute
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
First posted: 2017-02-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization
timeFrame: Day 7 after randomization
Secondary outcomes:
measure: Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)
timeFrame: Day 28 after randomization
measure: Number of Participants Who Develop Any ARB-associated Infections
timeFrame: Day 3, Day 7, Day 28, Month 6
measure: Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6
timeFrame: Day 28, Month 6
Other outcomes:
measure: Microbiome Disruption Indices (MDI) (16S rRNA Sequencing)
timeFrame: Day 0, Day 3, Day 7, Day 28
Locations:
city: Boston
country: United States
facility: Boston University - Boston Medical Center nursing home consortium
state: Massachusetts
Study officials:
affiliation: Microbiome Health Research Institute, (d/b/a OpenBiome)
name: Majdi Osman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.