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

Phase 2

Terminated

• Conditions: Intensive Care Units; Fecal Microbiota Transplantation
• Interventions: Drug: fecal microbiota transfer

• Registration Number: NCT03350178
• Lead Sponsor: MaaT Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2018-01-15
• Primary Completion: 2019-02-19
• Study Completion: 2019-02-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treated patients	fecal microbiota transfer	Treated wit FMT

Primary Outcome Measures

Name	Time	Method
Occurrence of FMT-related treatment emergent (serious) adverse events	through study completion, an average of 2 weeks	Occurrence of FMT-related treatment emergent (serious) adverse events

Secondary Outcome Measures

Name	Time	Method
Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage	through study completion, an average of 2 weeks	Based on bacterial culture, description of MDRB carriage. Resistance acquisition or eradication will be evaluated
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	through study completion, an average of 2 weeks	FMT procedure will be considered as good if it has been accepted without any particular reluctance
Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion	through study completion, an average of 2 weeks	occurrence of FMT-related treatment emergent (serious) adverse events

Trial Locations

Locations (2)

Salengro hospital; 🇫🇷 Lille, France

Bichat Hospital; 🇫🇷 Paris, France