A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carriage of extended spectrum beta-lactamase or carbapenemase-producing Enterobacteriaceae in high-risk patients

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

For patients:
- Adult patients (18 years at date of inclusion)
- Documented intestinal carriage of ESBL-E and / or CRE by stool culture at baseline (visit 0).
- IF COLONIZED WITH ESBL-E ONLY (WITHOUT CRE): At least one episode of symptomatic infection with ESBL-E requiring systemic antibiotic therapy within the last 180 days before date of inclusion (based on the last day of antibiotic therapy for that infection).;For donors:
- Be aged between 18 and 60 years.
- Be in good health without comorbidities or significant past medical history.
- Have a normal body weight (body mass index between 20 and 25 kg/m2).
- Have a normal macroscopic appearance of stool.
- Have a normal stool frequency (1-3x/day).

Exclusion Criteria

For patients:
- Pregnancy or planned pregnancy.
- Breastfeeding.
- Difficult / impossible follow-up.
- Allergy or other contraindication to one of the study drugs.
- Anatomic contraindication to the placement of a nasogastric tube.
- Recurrent aspirations.
- Resistance to colistin (defined as MIC > 2 mg/l) of any of the ESBL-E or CRE strains isolated at baseline.
- Estimated life expectancy < 6 months.
- Treatment with any systemic antibiotic on the day of inclusion.
- Severe immunodeficieny.
* Systemic chemotherapy *30 days from baseline or planned chemotherapy within the next 6 months.
* Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl.
* Prolonged use of steroids (prednisone equivalent * 60 mg per day for > = 30 days) or other immunosuppressive medications.
* neutropenia with absolute neutrophil count < 1000/*L.
* Solid organ transplant recipient.
* Hematopoeitic stem cell transplant recepients.
* Other causes of severe immunodeficiency.
- Hospitalization in an Intensive Care Unit.
- Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2.
- Severe food allergy (anaphylaxis, urticaria).;For donors:
- Not have an acute or chronic digestive disorder.
- Not have a risk behavior for infectious diseases (eg recent change of sexual partner, homosexual intercourse, drug use etc.).
- Not be affected by a chronic disease.
- Not be under long-term treatment.
- Not have had an acute illness or fever in the last 4 weeks.
- Not have stayed in a tropical zone in the last three months or have lived in tropics for many years.
- Not have taken antibiotics in the last 6 months.
- Not have received a tattoo, piercing etc. in the last 6 months.
- Not have undergone a gastroscopy or colonoscopy within the last 6 months.
- Not have received blood products in the past 12 months.
- Not have a history of typhoid fever.
- Not have been hospitalized aborad in the last 12 months.
- Not have stayed in the UK for more than six months between 1980 and 1996.