Fecal Microbiota Transplantation for Carbapenem Resistant Enterobacteriaceae

NCT04790565 | Completed Phase 2

• 1 other identifier: 0101-21
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, single center, prospective interventional non-comparative study for CRE carriers.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Outcome Measures

Primary Outcomes (1)

• CRE eradication

  Number of participants achieving CRE eradication , defined as 3 consecutive negative rectal cultures, with polymerase chain reaction preformed in the last sample. For patients with clinical infections, eradication definition will include a negative culture from the site of infection, if relevant at the time of eradication.

  28 days

Secondary Outcomes (6)

• CRE eradication rates at day 14, day 30 and 3 & 6 months

  days 7, 14, months 3, 6

• Mortality

  28-day and 6 months

• Bacteremia

  6 months

• CRE infection

  6 months

• Hospitalization days

  6 months

Study Arms (1)

Fecal microbiota transplantation (FMT)

EXPERIMENTAL

Patients will be given capsulized FMT, 15 capsules a day for two consecutive days after a fast of 8 hours before FMT. Patients will continue fasting for 2 hours after the intervention. Stool will be collected before and after the intervention for genomic analysis of CRE strains, analysis of microbiome and metabolome.

Biological: FMT

Interventions

FMT BIOLOGICAL

Fecal microbiota in frozen capsules

Fecal microbiota transplantation (FMT)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnant women Patients with severe neutropenia (\<100/µl) (for follow-up) Severe GVHD involving the gastrointestinal involvment (for follow-up) Patients with inflammatory bowel disease (Crohn's or ulcerative colitis) Patients with intestinal perforation or severe abdominal infection (for follow-up) Patients carrying a colostomy, ileostomy or similar Inability or contra-indication to take oral medications (intestinal obstruction, suspected perforation, peritonitis) (for follow-up) Severe food allergies Severe diarrhea (for follow-up) Inability to provide informed consent (for follow-up) Refusal of primary care physician Patients treated with antibiotics within the 2 days before fulfilling all other eligibility criteria (for follow-up)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Study Officials

• Michal Paul, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Infectious Diseases Institute

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: October 1, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: End of study
• Access Criteria: Academic use

Locations

IL (1)