Fecal Microbiota Transplantation for Carbapenem-resistant Enterobacteriaceae
Israel3 participantsStarted 2020-10-12
Plain-language summary
2:1, open-label, single center, randomized controlled trial comparing FMT vs. no intervention for CRE carriers,
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
We will include adult inpatients ≥18 years positive for CRE of any strain and resistance mechanism in rectal surveillance stool samples, with or without CRE clinical samples. We will mandate a positive rectal swab within one week before randomization. Several exclusion criteria may change throughout the patients' hospitalization and we will follow-up patients for these criteria until reaching eligibility or not (designed as (for follow-up)). Non-eligible patients discharged will be re-evaluated for inclusion when re-admitted.
We will exclude:
* Pregnant women
* Patients with severe neutropenia (\<100/µl) (for follow-up)
* Severe GVHD involving the gastrointestinal involvment (for follow-up)
* Patients with inflammatory bowel disease (Crohn's or ulcerative colitis)
* Patients with intestinal perforation or severe abdominal infection (for follow-up)
* Patients carrying a colostomy, ileostomy or similar
* Inability or contra-indication to take oral medications (intestinal obstruction, suspected perforation, peritonitis) (for follow-up)
* Severe food allergies
* Severe diarrhea (for follow-up)
* Inability to provide informed consent (for follow-up)
* Refusal of primary care physician
* Patients treated with antibiotics within the 2 days before fulfilling all other eligibility criteria (for follow-up)