Using fecal microbiota transplantation to treat antibiotic-resistant infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of fecal microbiota transplantation (FMT) to eliminate carbapenem-resistant Enterobacteriaceae (CRE) from the gut. The study aims to compare the effectiveness of donor FMT against a placebo FMT in patients who are colonized with these multi-drug resistant bacteria. By restoring healthy gut microbiota, the trial seeks to enhance colonization resistance and reduce the risk of infections associated with CRE. The study is designed as a randomized controlled trial to provide robust evidence on the efficacy of this approach.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion criteria

* 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

Where it's running

• Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Gianluca Ianiro — Fondazione Policlinico Gemelli IRCCS
• Study coordinator: Gianluca Ianiro
• Email: gianluca.ianiro@hotmail.it
• Phone: 3381929859

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Phase 1/2 Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT05791396

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• Using fecal transplantation to eliminate drug-resistant bacteria

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• Rectal swab detection of ESBL, carbapenemases, and high-level cephalosporinase to predict C3G-resistant Enterobacteriaceae infections in ICU patients

  This study tests whether a rectal swab that finds ESBL, carbapenemases, or high-level cephalosporinase can predict which adult ICU patients at Strasbourg are likely to get C3G-resistant Enterobacteriaceae infections.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07345923

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.