A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection

NCT02394275 | Terminated Phase 2 Results DMC

• 1 other identifier: CDI.FMT.2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The primary goal of this proposal is to study the outcome of patients with recurrent Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the safety of FMT and to determine the clinical response, treatment failure and relapse rate in patients treated with frozen-and-thawed FMT; to assess the functional health and well-being of patients in each arm using the validated tool, and to determine the feasibility of providing standardized FMT in multiple centres across Canada, including community hospitals. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• No Recurrence of CDI-related Diarrhea

  No recurrence of CDI-related diarrhea at 8 weeks following last FMT without the need for an intervention (antibiotics or additional FMT) specifically for recurrence of CDI

  13 weeks

Secondary Outcomes (1)

• Safety of FMT

  13 weeks

Study Arms (1)

Single arm:

EXPERIMENTAL

Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

All eligible patients will receive fecal microbiota transplant

Also known as: Human Biotherapy

Single arm:

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Able to provide informed consent.
• Laboratory or pathology confirmed diagnosis of recurrent CDI with symptoms (defined below) within the previous 180 days.
• ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for at least 5 days.

You may not qualify if:

• Planned or actively taking an investigational product for another study.
• Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L
• Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
• Peripheral white blood cell count \> 30.0 x 109/L AND temperature \> 38.0 oC
• Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
• Presence of colostomy or ileostomy.
• Unable to tolerate FMT or enema for any reason.
• Anticipated requirement for systemic antibiotic therapy for more than 7 days during the 12 week study period.
• Actively taking Saccharomyces boulardii or probiotics other than yogurt.
• No symptoms consistent with CDI, off CDI antibiotic therapy for 3 or more weeks
• Severe underlying disease such that the patient is not expected to survive for at least 30 days.
• Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Marek Smieja
• Organization: St. Joseph's Healthcare Hamilton, ON

smiejam@mcmaster.ca

905 521 6021

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 20, 2015
• Study Start: March 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 31, 2019
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)