Evaluation of Heterologous Fecal microbiotA Transfer in I... | NCT03350178

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

NCT03350178

Sponsor

MaaT Pharma

Status

Terminated

Last Update Posted

Mar 8, 2019Actual

Enrollment

8Actual

Phase

Phase 2

Conditions

Intensive Care Units
Fecal Microbiota Transplantation

Interventions

fecal microbiota transfer

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment shortened

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Feb 19, 2019Actual

Completion Date

Feb 19, 2019Actual

First Submitted Date

Nov 14, 2017

First Submission Date that Met QC Criteria

Nov 20, 2017

First Posted Date

Nov 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2019

Last Update Posted Date

Mar 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
treated patients	Experimental	Treated wit FMT	Drug: fecal microbiota transfer

Name	Type	Description	Arm Group Labels	Other Names
fecal microbiota transfer	Drug	transfer of fecal microbiota from healthy donor to the patients	treated patients

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Salengro hospital		Lille			France
Bichat Hospital

ID	Term
D001691	Biological Therapy
D013812	Therapeutics