Faecal Microbiota Transplantation, Multidrug Resistant Organisms
Conditions
Brief summary
The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).
Detailed description
The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.
Interventions
25-30 capsules of faecal material
OTHERPlacebo
25-30 placebo capsules
Sponsors
Hvidovre University Hospital
Aarhus University Hospital
Odense University Hospital
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with MRO clearance | 8 weeks | Number of participants with MRO clearance after eight weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The results from the test will be positive or negative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with MRO clearance | 16 weeks | Number of participants with negative PCR for MRO on rectal swab and faecal culture negative for MRO after 16 weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The result from the test will be positive or negative |
| Number of participants with adverse events. | 8 weeks, 16 weeks and 6 months. | Number of participants with adverse events both severe and non-severe. |
| Comparison of the frequency of invasive infections | 6 months | Comparison of the frequency of invasive infections with the same MRO as the intestinal carriage between the FMT and the placebo group. |
| Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group. | 6 months | Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group. |
| Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group. | 8 weeks and 16 weeks | Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group. |
Countries
Denmark
Outcome results
None listed