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New treatment option for Enterobacteriaceae Infections
Official title FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae
ClinicalTrials.gov ID: NCT04759001
What this study is testing
What is Donor FMT?
Donor FMT is an investigational medicine, being studied as a potential treatment for enterobacteriaceae infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 18 years old or older
- Current evidence of gut colonisation (diagnosed with rectal swab) by CRE
- Ability to give their consent to be included in the study.
You likely can't join if
- Another known gastrointestinal infection apart from C. difficile infection
- Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome...
- Previous colorectal surgery or cutaneous stoma
- Food allergies
- Current or recent (\<2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors...
- Decompensated heart failure or heart disease with ejection fraction lower than 30%
See the full eligibility criteria
- 18 years old or older
- Current evidence of gut colonisation (diagnosed with rectal swab) by CRE
- Ability to give their consent to be included in the study.
- Another known gastrointestinal infection apart from C. difficile infection
- Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)
- Previous colorectal surgery or cutaneous stoma
- Food allergies
- Current or recent (\<2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin)
- Decompensated heart failure or heart disease with ejection fraction lower than 30%
- Severe respiratory insufficiency
- Psychiatric disorders
- Pregnancy
- Unable to give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.