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

Fecal Microbiota Transplantation Clinical Trial

— HAPY3  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03350178
• Other study ID #: MPICU01
• Status: Terminated
• Phase: Phase 2
• Start date: January 15, 2018
• Est. completion date: February 19, 2019

Study information

• Verified date: March 2019
• Source: MaaT Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 19, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation
• Intensive Care Units

Intervention

Drug:
• fecal microbiota transfer
transfer of fecal microbiota from healthy donor to the patients

Locations

Country	Name	City	State
France	Salengro hospital	Lille
France	Bichat Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
MaaT Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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