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Search / Trial NCT05742074

The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers

Launched by HVIDOVRE UNIVERSITY HOSPITAL · Feb 14, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called faecal microbiota transplantation (FMT) can help eliminate multidrug resistant organisms (MRO) from the intestines. MROs are harmful bacteria that are tough to treat because they don’t respond to many antibiotics. By using FMT, which involves transferring healthy bacteria from a donor's stool into a patient's gut, researchers hope to make the intestines resistant to these hard-to-treat infections. This could help prevent serious infections that require strong antibiotics.

To participate in the trial, you need to be at least 18 years old and have tested positive for MROs in your intestines. You should be able to understand and speak either Danish or English and be capable of swallowing capsules. However, if you currently have a serious infection, a severe immune system problem, or recent abdominal surgery, you wouldn't be eligible. Participants in the trial will receive the treatment and be monitored for its effects, helping researchers understand if FMT can be a successful way to fight these resistant infections.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age: minimum 18 years
  • Positive rectal PCR and/or culture for MRO
  • Ability to speak and understand Danish or English
  • Capable of swallowing the capsules
  • Exclusion Criteria:
  • Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.
  • Severe immune deficiency (defined as current chemo treatment or neurofilocytes \< 1000/mm3
  • Pancreatitis, defined by pancreatic amylases above the upper reference limit
  • Planned or recent abdominal surgery (within 14 days)
  • Parenteral nutrition
  • Current antibiotic treatment of the same MRO as intestinal carriage
  • Terminal disease with expected survival under three months
  • Sepsis defined according to Surviving Sepsis Campaign guidelines
  • Pregnant or lactating women

About Hvidovre University Hospital

Hvidovre University Hospital is a leading clinical research institution located in Denmark, dedicated to advancing medical science through rigorous clinical trials and innovative healthcare solutions. As a prominent academic hospital, it integrates patient care with research, fostering collaboration among multidisciplinary teams of healthcare professionals, researchers, and academic institutions. Hvidovre University Hospital is committed to enhancing patient outcomes by conducting high-quality clinical studies across various therapeutic areas, ensuring adherence to ethical standards and regulatory compliance. Its state-of-the-art facilities and focus on translational medicine position the hospital as a key player in the development of new treatments and therapies, ultimately contributing to the improvement of public health.

Locations

Hvidovre, Copenhagen, Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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