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Search / Trial NCT05791396

FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Fecal Microbiota Transplantation Enterobacteriaceae Multi Drug Resistant Bacteria

ClinConnect Summary

This clinical trial is investigating a treatment called fecal microbiota transplant (FMT) to help eliminate harmful bacteria in the gut known as carbapenem-resistant Enterobacteriaceae (CRE), which are difficult to treat due to antibiotic resistance. Antibiotic resistance is a significant health issue, and researchers believe that FMT, which involves transferring healthy bacteria from a donor’s stool to a patient’s gut, could be an effective way to restore a healthy balance and fight these infections.

To participate in this study, individuals must be 18 years or older and have been diagnosed with CRE through a rectal swab within the last 15 days. However, there are a few reasons someone might not be eligible, such as having certain gastrointestinal disorders, having had major surgery on the colon, or being pregnant. Those who join the trial can expect to undergo specific procedures to help evaluate the effectiveness of the treatment. This study is currently recruiting participants, and the goal is to better understand how FMT can help combat antibiotic-resistant infections while ensuring safety and efficacy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • \>18 years;
  • CRE diagnosed with rectal swab \<15 days before evaluation;
  • Ability to undergo study procedures and to give informed consent.
  • Exclusion Criteria:
  • Active chronic gastrointestinal disorders;
  • Previous colorectal surgery;
  • Major comorbidities;
  • Pregnancy/breastfeeding;
  • Psychiatric disorders.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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