Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03350178
NCT03350178TerminatedPhase 2

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

MaaT Pharma2 sites in 1 country8 target enrollmentStarted: January 15, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
8
Locations
2
Primary Endpoint
Occurrence of FMT-related treatment emergent (serious) adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

treated patients

Experimental

Treated wit FMT

Intervention: fecal microbiota transfer (Drug)

Outcomes

Primary Outcomes

Occurrence of FMT-related treatment emergent (serious) adverse events

Time Frame: through study completion, an average of 2 weeks

Occurrence of FMT-related treatment emergent (serious) adverse events

Secondary Outcomes

  • Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage(through study completion, an average of 2 weeks)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(through study completion, an average of 2 weeks)
  • Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion(through study completion, an average of 2 weeks)

Investigators

Sponsor
MaaT Pharma
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Unknown
Not Applicable
Safety and Efficacy of Heterologous FMT by SQIMC-md Capsule in Mild-moderate Ulcerative Colitis PatientsUlcerative Colitis
NCT04034758Tongji Hospital99
Completed
Not Applicable
Efficacy and Safety of Fecal Microbiota Transplantation in Peripheral Psoriatic ArthritisPsoriatic Arthritis
NCT03058900Odense University Hospital31
Recruiting
Not Applicable
Efficacy and Safety of Fecal Microbiota TransplantationFecal Microbiota Transplantation
NCT04706611Guangzhou First People's Hospital300
Unknown
Not Applicable
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile ColitisClostridium DifficileClostridium Difficile Infection
NCT01942447University Hospital Tuebingen30
Recruiting
Not Applicable
Safety and Efficacy of Fecal Microbiota TransplantationFunctional DysphoniaClostridium Difficile InfectionMultidrug -Resistant InfectionObesityDiabetes MellitusUlcerative ColitisPseudo-ObstructionCarbapenem-Resistant Enterobacteriaceae InfectionVancomycin Resistant Enterococci InfectionDysbiotic Bowel SyndromeMRSA EnteritisGraft-versus-host DiseaseAtopy or AllergyMultiple SclerosisHepatic EncephalopathyIdiopathic Thrombocytopenic PurpuraPsoriatic ArthropathyIrritable Bowel SyndromeConstipationAutismLiver DiseaseAlopeciaCeliac DiseaseCrohn DiseaseAlcohol DependenceMultiple Organ Dysfunction SyndromePseudomembranous Enterocolitis
NCT04014413Chinese University of Hong Kong450