Using faecal microbiota transplantation to eliminate multidrug resistant organisms in the intestine
The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers - a Multicentre, Randomized, Double-blinded and Placebo-controlled Study
This study is testing if a treatment using healthy gut bacteria can help people who carry hard-to-treat germs in their intestines get rid of them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre, Copenhagen) |
| Trial ID | NCT05742074 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of faecal microbiota transplantation (FMT) in eradicating multidrug resistant organisms (MRO) from the intestines of carriers. It is a randomized, double-blinded, and placebo-controlled study involving 80 participants who will receive either FMT or a placebo. Participants will consume 25-30 capsules of FMT or placebo over one or three days, and their intestinal microbiome will be analyzed through rectal swabs and faecal samples at baseline and 16 weeks post-treatment. The goal is to determine if FMT can induce resistance to MRO colonization, potentially preventing serious infections that are difficult to treat.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are positive for multidrug resistant organisms in their intestines.
Not a fit: Patients currently experiencing invasive infections with multidrug resistant organisms or those with severe immune deficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of invasive infections caused by multidrug resistant organisms.
How similar studies have performed: Previous studies have shown promise in using faecal microbiota transplantation for various conditions, but the specific application for multidrug resistant organisms is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hvidovre, Copenhagen
- Hvidovre Hospital, Copenhagen University — Hvidovre, Copenhagen, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.