A Phase 2/3 interventional study of Fecal Microbiota Transplantation (FMT) in Infection, sponsored by Susy Hota. Suspended at 13 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Susy Hota · Phase 2/3, Interventional, and Treatment
Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in death in 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor to a recipient to alter the composition of gut microbes. Early studies support its use for eliminating CPE carriage but definitive studies are lacking. The investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial comparing the effectiveness of FMT with no intervention (standard of care) in eliminating intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and retain 40 patients over 12 months, and to provide FMT made at a central site to at least one off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6 and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and, intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes will be collected but not analyzed in this feasibility study.
This is a multisite, open-label randomized controlled internal pilot trial designed to assess the feasibility of a larger trial aimed at determining the effectiveness of fecal microbiota transplantation (FMT) by enema in short and long term intestinal decolonization of carbapenemase-producing Enterobacteriaceae (CPE). Forty (40) asymptomatic adult patients intestinally colonized with CPE will be allocated in a 1:1 ratio to receive a bowel preparation followed by FMT by enema route, versus standard of care (no intervention). FMT will be provided by the University of Toronto Microbiota Therapeutics Outcomes Program (MTOP), using standardized operating procedures for recruiting and screening FMT donors, manufacturing FMT and administering FMT by enema. The feasibility outcomes are: successful randomization of 40 patients within 12 months, retention of >90% (36/40) of patients up to 6 months, and provision of FMT at a non-primary study site in at least one patient. Data on the clinical and exploratory outcomes will be collected but not analyzed in this pilot study. The primary clinical outcome is incidence of intestinal decolonization of CPE at 3 months. Secondary clinical outcomes include: time to decolonization of CPE; incidence of CPE clinical infections up to 12 months post-intervention; incidence of intestinal decolonization of CPE and other antibiotic-resistant organisms (extended spectrum beta-lactamase Enterobacteriaceae - ESBLs and vancomycin-resistant Enterococci - VRE) at 1, 3, 6 and 12 months post-intervention; and, safety profile. As an exploratory outcome, changes in fecal microbiome composition will be examined before and after intervention. This study leverages existing support, research infrastructures and expertise - including the Toronto Invasive Bacterial Diseases Network (TIBDN), Toronto Antimicrobial Resistance Research Network (TARRN), and the University of Toronto Microbiota Therapeutics Outcomes Program (MTOP) - to optimize feasibility regarding patient recruitment and FMT administration.
This is the only study on the registry with Susy Hota as lead sponsor.
Counted across the registry records on this site, refreshed daily.
≥ 1 rectal swab, groin, stool, or urine specimen positive for a CPE within the past 1 month.
Exclusion Criteria:
Significantly immunocompromised patients .
Bowel lavage preparation followed by FMT administered by enema, given on 3 occasions. Fecal filtrate for FMT will be prepared from 50 g of healthy donor stool, homogenized, and diluted in 300 mL sterile normal saline.
Biological: Fecal Microbiota Transplantation (FMT)
Patients in this arm will not receive intervention and will be on standard of care .
Feces from healthy donor
Incidence of intestinal colonization of patients with CPE 3 months after intervention.
Incidence of CPE colonization in FMT arm vs control arm at 3 months
Time frame: 3 months
Randomization rate in study
Completion of randomization of 40 study participants during the study period will be used to indicate feasibility of the study.
Time frame: 12 months
Proportion of patients retained in study for up to 6 months
A retention of 90% of patients up to 6 months in the study will be used to indicate feasibility.
Time frame: 6 months
Incidence of CPE decolonization in FMT-treatment and non-treatment groups at 1, 6 and 12 months.
As above
Time frame: 1, 6, and 12 months
Time to CPE decolonization in FMT-treatment and non-treatment groups.
As above
Time frame: 1, 3, 6, and 12 months
Incidence of CPE clinical infection in FMT treatment and non-treatment groups over 12 months.
As above
Time frame: 1, 3, 6, and 12 months
Incidence of extended spectrum beta-lactamase organisms (ESBL) and vancomycin-resistant Enterococci (VRE) intestinal colonization at 0, 1, 3, 6 and 12 months in FMT treatment and non-treatment groups.
Changes in colonization status of other antimicrobial resistant organisms over the study period
Time frame: 1, 3, 6, and 12 months
Incidence of solicited and unsolicited adverse and serious adverse events in both groups
Participants will be asked to report adverse and serious adverse events will be throughout the study period and will be asked specifically about adverse events during study visits
Time frame: 3 months
Number of patients with all-cause mortality at 30 days post-randomization
As above
Time frame: 1 month
Changes in composition and diversity of fecal bacterial phyla (as measured by 16s ribosomal ribonucleic acid sequencing) in both intervention groups
As above
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.