Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection

NCT03834038 | Completed Results

• 1 other identifier: CDI.LYO.FMT
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.

Conditions

Recurrent Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT

  No recurrence of CDI-related diarrhea at 13 weeks following last FMT without the need for an intervention antibiotics or additional FMT specifically for CDI recurrence.

  13 weeks from last FMT

Study Arms (1)

Open Label Lyophilized Fecal Microbiota Transplantation

EXPERIMENTAL

Eligible participants with history of recurrent or refractory CDI

Drug: Lyophilized Fecal Microbiota Transplantation

Interventions

Lyophilized Fecal Microbiota Transplantation DRUG

Lyophilized FMT

Open Label Lyophilized Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 12 years or older.
• Able to provide informed consent.
• Willing and able to comply with all the required study procedures.
• A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment unless patient taking treatment specifically for CDI for more than 3 months.
• History of at least ≥ 2 recurrent CDI where recurrence is defined as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy for each episode and/or ongoing symptoms consistent with CDI\* (defined below) despite at least 7 days of treatment using oral vancomycin at a minimum dose of 250 mg four times daily.
• Symptoms of CDI include: diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea

You may not qualify if:

• Planned or actively taking another investigational product
• CDI symptom-free for 3 or more weeks following completion of CDI treatment
• Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L
• Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
• Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
• Presence of colostomy
• Unable to tolerate FMT or enema for any reason.
• Requiring systemic antibiotic therapy for more than 7 days.
• Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed
• Severe underlying disease such that the patient is not expected to survive for at least 30 days.

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

One of the significant limitations of the study was the open-labelled nature of the study and the introduction of inherent bias but attempts were made to reduce the outcome bias by tracking the consistency and the number of bowel movements during the 13-week follow-up period; the stool was tested for CD toxin/gene when the participants experienced symptoms consistent with recurrent CDI.

Results Point of Contact

• Title: Dr. Christine Lee
• Organization: Vancouver Island Health Authority

christine.lee@islandhealth.ca

250-519-1898

Study Officials

• Christine Lee, MD

  Vancouver Island Health Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: October 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 17, 2020
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)