HAPY3: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY

• Sponsor: MaaT Pharma (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03350178
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Arm: 1
• Actual Duration (Months): 13.1
• Patients Per Site: 4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Units; Fecal Microbiota Transplantation	Drug: fecal microbiota transfer	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
• Actual Study Start Date: Jan 15, 2018
• Actual Primary Completion Date: Feb 19, 2019
• Actual Study Completion Date: Feb 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treated patients Treated wit FMT	Drug: fecal microbiota transfer; transfer of fecal microbiota from healthy donor to the patients

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salengro hospital	Lille		France
2	Bichat Hospital	Paris		France	75018

Sponsors and Collaborators

• MaaT Pharma

Investigators

• Principal Investigator: Anahita Rouze, CHRU Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MaaT Pharma
• ClinicalTrials.gov Identifier: NCT03350178
• Other Study ID Numbers: MPICU01
• First Posted: Nov 22, 2017
• Last Update Posted: Mar 8, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 8, 2019