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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intensive Care Units, Fecal Microbiota Transplantation

Intervention / Treatment
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* Drug: fecal microbiota transfer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treated patients<br>Treated wit FMT | Drug: fecal microbiota transfer<br>* transfer of fecal microbiota from healthy donor to the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of FMT-related treatment emergent (serious) adverse events | Occurrence of FMT-related treatment emergent (serious) adverse events | through study completion, an average of 2 weeks | 

Secondary Outcome Measures

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