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โ† Trials
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FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

RecruitingPhase 1, Phase 2Ages 18 Years - 85 YearsAllFondazione Policlinico Universitario Agostino Gemโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Antibiotic resistance (AR) is a critical public health threat and one of the greatest challenges of the 21st century. In an estimate of 2019, nearly 700.000 infections and 33.000 attributable deaths from multi-drug-resistant bacteria (MDRB) have occurred in Europe in 2015. The gastrointestinal tract is a large reservoir for MDRB, and the gut microbiota can harbor a collection of AR genes, called gut resistome. Preliminary nonrandomized evidence suggests that fecal microbiota transplant (FMT) could be a promising treatment option to eradicate MDRB, but established evidence, as well as mechanisms that underpin this therapeutic pathway, are still unavailable. Leveraging our expertise in FMT (OU1), microbiome (OU2) and MDRB (OU3), we aim to evaluate the efficacy of FMT (from donors with limited presence of AR genes) in eradicating intestinal MDRB through a randomized controlled trial and ide

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Donor - FMT
  • Placebo FMT
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Where

1 site
Giovanni Cammarota
Roma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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