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

NCT ID: NCT03350178

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-02-19

Brief Summary

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.

Conditions

Intensive Care Units; Fecal Microbiota Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

treated patients

Treated wit FMT

Group Type: EXPERIMENTAL

fecal microbiota transfer

Intervention Type: DRUG

transfer of fecal microbiota from healthy donor to the patients

Interventions

fecal microbiota transfer

transfer of fecal microbiota from healthy donor to the patients

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MaaT Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anahita Rouze

Role: PRINCIPAL_INVESTIGATOR

CHRU LILLE

Locations

Salengro hospital

Lille, , France

Bichat Hospital

Paris, , France

Countries

France

Other Identifiers

MPICU01

Identifier Type: -

Identifier Source: org_study_id