Fecal Microbiota Transplantation for Carbapenem-resistant Enterobacteriaceae
Carbapenem-Resistant Enterobacteriaceae Infection
About this trial
This is an interventional treatment trial for Carbapenem-Resistant Enterobacteriaceae Infection
Eligibility Criteria
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)
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Fecal microbiota transplantation (FMT)
Control
FMT regimen: Patients will be given capsulized FMT 15 capsules a day for two consecutive days after a fast of 8 hours before FMT. Stool will be collected before and after the intervention for genomic analysis of CRE strains, analysis of microbiome and metabolome.
Routine follow-up