A Phase 2/3 interventional study of Allogenic FMT and Autologous FMT in Resistance Bacterial, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Phase 2/3, Interventional, and Treatment
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all.
The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.
This double-blind controlled randomized study will test the efficacy of Fecal Microbiota Transfer (FMT) on gut Multiple Drug Resistant Organism (MDRO) colonization.
Participants:
The study targets hospitalized patients (>18 years old) that need to stay in isolation because of colonization by Carbapenem-resistant Enterobacteriales (CRE), non-E. coli Enterobacteriales that produce extended spectrum beta-lactamase (ESBL) or Multi Drug Resistant (MDR) Pseudomonas and MDR Acinetobacter species. Participants will be randomized in two groups (allogenic and autologous FMT). Additionally a third group of participants will be monitored without intervention.
Treatment:
Participants in the allogenic FMT- group will receive treatment using healthy donor microbiota preferably through naso-duodenal/-jejunal administration (Cortrak). Donor material will be supplied by the Ghent Stool Bank. The colonization status will be monitored on a regular basis (at least once per week) by culturing fecal swabs. Additionally fecal samples will be taken on fixed time points for microbial composition analysis (16S ribosomal ribonucleic acid metagenomics).
Controls:
Participants in the autologous FMT-group will will receive an FMT with their own microbiota to account for the effects of the intervention itself. Participants in the "no intervention" group will not receive an FMT. Both control groups will be monitored and sampled identically to the allogenic FMT-group.
Outcome:
The primary outcome (MDRO-decolonization rate in treatment versus control) will be evaluated 1 month after FMT. Secondarily, safety and tolerability of the treatment will be assessed. The patients will be monitored up to 1 year after treatment to evaluate microbiome composition and to define parameters in the microbiome that are associated with clinical outcome.
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the allogenic FMT- group will receive FMT-treatment using healthy donor microbiota supplied by the Ghent Stool Bank. The donor stool (50g) is processed shortly after production and tested intensively. It's frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak).
Biological: Allogenic FMT
Participants in the autologous FMT- group will receive FMT-treatment using their own microbiota to account for effects due to the treatment itself. Their stool is processed as close to the treatment as feasible. It's processed and frozen at -80°C until administration via naso-duodenal/-jejunal tube (Cortrak).
Biological: Autologous FMT
Participants in the "No intervention"-group will not receive any treatment but will be monitored similarly as the "Allogenic FMT" and "Autologous FMT" groups.
Transplantation of fecal microbiota from a donor into a recipient
Also known as: Fecal Microbiota Transplantation with donor stool, Fecal Microbiota Transfer with donor stool
Transplantation of autologous fecal microbiota
Also known as: Fecal Microbiota Transplantation with own stool, Fecal Microbiota Transfer with own stool
Number of participants with decolonization success/failure
These participants were screened positive for MDRO's in stool cultures before treatment and monitored at least once per week up to 1 month after treatment. "Decolonization" = 3 consecutive negative cultures in minimal time span of 2 weeks.
Time frame: 1 month after treatment
Side effects
Monitor adverse events
Time frame: up to 1 year after treatment
Treatment effect on microbial community in participants
Evaluation of gut bacterial composition changes in participants over time pre- and post-treatment with 16S ribosomal ribonucleic acid based metagenomic analysis.
Time frame: up to 1 year after treatment
Treatment tolerability
The tolerability of the treatment is monitored with an in-house developed questionnaire considering the participant's opinion before, during and after the treatment on a score of 1 (very bad) to 5 (very good).
Time frame: 1 month after treatment
Plan to share: Yes — Participant data will be pseudonymized, not traceable to participant identity except for clinical staff. All participant data, questionnaires, colonization and sequencing data annotation will be collected in "open REDCap" (TLS encrypted secure web platform) to ensure traceability and safekeeping of the data. Data is stored and backed-up for at least 20 years on a secured server. Following data will be shared with other researchers: * baseline characteristics (age, BMI, sex...) * colonization status * analyzed gut microbial sequencing data * clinical follow-up data
Supporting information: Study protocol, Sap
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University Hospital, Ghent