Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Rec… (NCT06533800) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection
24 participantsStarted 2024-09-15
Plain-language summary
Caratterizzazione della composizione microbica intestinale nei donatori di FMT e nei pazienti affetti da rCDI al tempo basale e a seguito del trapianto di microbiota fecale. Negli stessi time point valutare il resistoma associato alla comunità microbica rilevata.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* patients with rCDI (\> 18 years) to whom faecal microbiota transplantation is indicated, without other pathologies or prolonged hospitalization periods
* donors: healthy volunteers aged between 18 and 50 years
* Patients capable of expressing consent
Exclusion criteria
* antibiotic therapies in the last 30 days
* treatments with prebiotics - probiotics - postbiotics in the last 60 days
* colonization by MDR or XDR pathogens
* presence of pre-existing or ongoing intestinal pathologies (Inflammatory Intestinal Diseases, chronic hepatitis, celiac disease, neoplasms, previous large intestinal resections)
* ongoing diarrhea of any origin (defined as more than 6 watery stools per day and/or faecal volume greater than 250 ml in 24 hours)
* severe septic state in progress
* for donors: drug addiction, promiscuous sexual behaviour, use of drugs that can be excreted in the faeces with potential risk for recipients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of gut microbiota e associated resitome