RecruitingPhase 2Phase 3NCT04188743

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

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


Sponsor

University Hospital, Ghent

Enrollment

150 participants

Start Date

Dec 18, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAllogenic FMT

Transplantation of fecal microbiota from a donor into a recipient

BIOLOGICALAutologous FMT

Transplantation of autologous fecal microbiota


Locations(1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04188743