Using donor microbiota to treat drug-resistant bacterial infections

DEKODON: Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)

This study is testing if using healthy gut bacteria from donors can help hospitalized patients get rid of stubborn drug-resistant infections in their gut.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Ghent (other)
• Locations: 1 site (Ghent, Oost-Vlaanderen)
• Trial ID: NCT04188743 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Fecal Microbiota Transfer (FMT) in decolonizing patients with Multiple Drug Resistant Organisms (MDROs) in their gut. Hospitalized patients over 18 years old, who are colonized by specific resistant bacteria, will be randomized into three groups: one receiving allogenic FMT from healthy donors, another receiving autologous FMT from their own microbiota, and a control group receiving no intervention. The primary outcome will be the decolonization rate measured one month post-treatment, with additional monitoring of gut microbial composition for up to a year.

Who should consider this trial

Good fit: Ideal candidates are hospitalized patients over 18 years old with confirmed colonization by specific drug-resistant bacteria requiring isolation.

Not a fit: Patients with inflammatory bowel disease, chronic liver disease, or those with existing immune deficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the duration of isolation for patients and improve their overall treatment outcomes.

How similar studies have performed: Previous studies have shown promising results with FMT in treating various gastrointestinal conditions, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Participants must be at least 18 years of age, and must sign the 'informed consent' form and thus agree with the data collection, sampling and FMT.
* At least 2 consecutive confirmations of MDRO colonization in faeces, which complicate the necessary follow-up and/or therapy for the patient.
* Participants must be able to endure the treatment (evaluated by treating physician).

Exclusion Criteria:

* Inflammatory bowel disease (Crohn's disease, ulcerative colitis ...)
* Diagnosed hereditary blood disease (Haemophilia, Von Willebrand ...)
* Chronic liver disease
* Active drug use or alcohol abuse / dependence, which according to the researchers' opinion may interfere with the patient's participation in the study
* Simultaneous use of probiotics (except yoghurt)
* Existing immune deficiency (congenital or acquired), or concomitant immunomodulatory treatment (including systemic corticosteroids) in the 12 weeks prior to randomization, nasal or inhaled corticosteroid use is permitted
* Positive pregnancy test (or potentially pregnant)
* Breastfeeding
* Severe food allergy (anaphylaxis, urticarial)
* Antibiotic treatment up to 7 days before FMT, or planned to start within one month after FMT.

Where this trial is running

Ghent, Oost-Vlaanderen

• Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)

Study contacts

• Principal investigator: Bruno Verhasselt, Prof. Dr. — University Hospital, Ghent
• Study coordinator: Bruno Verhasselt, Prof. Dr.

Conditions: Resistance Bacterial, Fecal Microbiota Transplantation, Hospitals, Isolation, Drug Resistance, Multiple, Bacterial, Gram-Negative Bacteria, Gastrointestinal Microbiome