Fecal Microbiota Transplantation for Carbapenem-resistant Enterobacteriaceae

NCT04146337 | Completed Phase 2

• 1 other identifier: 0338-19
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

2:1, open-label, single center, randomized controlled trial comparing FMT vs. no intervention for CRE carriers,

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection

Outcome Measures

Primary Outcomes (1)

• CRE eradication

  Number of participants achieving CRE eradication at 28 days, 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 7, day 14, 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 (2)

Fecal microbiota transplantation (FMT)

EXPERIMENTAL

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

Biological: FMT

Control

NO INTERVENTION

Routine follow-up

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:

• We will exclude:
• 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

• Haggay Bar Yoseph, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: October 12, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

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

Locations

IL (1)