Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY (HAPY3)

MaaT Pharma

Status and phase

Terminated

Phase 2

Conditions

Intensive Care Units

Fecal Microbiota Transplantation

Treatments

Drug: fecal microbiota transfer

Study type

Interventional

Funder types

Industry

Identifiers

NCT03350178

MPICU01

Details and patient eligibility

About

ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18
Patients hospitalized in ICU
Patients under mechanical ventilation
Patients with an expected length of stay of at least 4 days after inclusion
Patients identified with an MDRB digestive carriage, determined by a positive rectal swab previously performed during ICU stay, according to usual screening
Expected antibiotic (ATB) duration < 10 days
Informed written consent from the patient
In unconscious patients who are not able to give consent for inclusion in the study, relatives (next-of-kin) give assent on every patient's behalf, and patients will be later given the opportunity to withdraw from the study

Exclusion criteria

Patients with a high risk of death within 5 days according to investigator's opinion, or subjected to therapeutic limitation decisions
Antibiotherapy of more than 4 consecutive days at inclusion
Confirmed or suspected intestinal ischemia
Confirmed or suspected toxic megacolon or gastrointestinal perforation
Any gastro-intestinal bleeding in the past 3 months
Any history of abdominal surgery in the past 3 months
Any history of chronic digestive disease or gastro-intestinal resection
Any counter indication for Trendelenburg position
Neutropenia (neutrophil counts < 500 cells/µL)
Ongoing immunosuppressive therapy (chemotherapy, any immunosuppressive agents, excluding corticosteroids < 0,5 mg/kg/d of equivalent prednisolone)
Enrollment in another trial that may interfere with this study
Known allergy or intolerance to trehalose or maltodextrin and latex
Pregnancy or breastfeeding
Patients with EBV- serology