Back to resultsMulticentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
Primary Purpose
Clostridia Difficile Colitis, Clostridium Difficile Diarrhea
Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lyophilized fecal microbiota transplant
Lyophilized sterile fecal filtrate
Sponsored by
About this trial
This is an interventional treatment trial for Clostridia Difficile Colitis
Eligibility Criteria
Inclusion Criteria:
- at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
- CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
- Ability to provide informed consent
- Females and males must agree to effective contraception for the duration of the study
Exclusion Criteria:
- Severe or fulminant colitis
- Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
- Those taking or planning to take an investigational drug within 3 months of enrollment
- Chemotherapy or radiation therapy
- Oropharyngeal or significant esophageal dysphagia
- Ileus or small bowel obstruction
- Pregnant or planning to become pregnant within 3 months
- Breastfeeding or planning to breastfeed during the trial
- Active infection requiring antibiotics
- Life expectancy <6 months Those with history of total colectomy
Sites / Locations
- University of Alberta Hospital
- University of British Columbia
- University of British Columbia
- Mcgill University Health Centre
- University Of Calgary
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
LFMT
LSFF
Arm Description
Lyophilized fecal microbiota transplant capsules
Lyophilized sterile fecal filtrate capsules
Outcomes
Primary Outcome Measures
Resolution of RCDI
Proportion of patients without RCDI
Secondary Outcome Measures
Resolution of RCDI
Proportion of patients with sustained cure
Serious Adverse Events
Mortality directly attributable to CDI or treatment
Serious Adverse Events
Infection directly attributable to treatment
Minor Adverse Events
Nausea
Minor Adverse Events
Vomiting
Minor Adverse Events
Abdominal discomfort
Difficulty swallowing capsules
Reported by patients as ranging between none, moderate or severe
Fever
Temperature of >37.8C
Full Information
NCT ID
NCT03806803
First Posted
January 14, 2019
Last Updated
October 10, 2023
Sponsor
University of Alberta
Collaborators
University of British Columbia, University of Calgary, McGill University
1. Study Identification
Unique Protocol Identification Number
NCT03806803
Brief Title
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
Official Title
A Multicenter Double Blind Randomized Study Comparing the Efficacy of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplantation (FMT) in the Management of Recurrent Clostridioides Difficile Infection (CDI)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
University of British Columbia, University of Calgary, McGill University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works.
Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups.
Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.
Detailed Description
This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules.
Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridia Difficile Colitis, Clostridium Difficile Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double blind randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
LFMT and LSFF appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care.
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LFMT
Arm Type
Active Comparator
Arm Description
Lyophilized fecal microbiota transplant capsules
Arm Title
LSFF
Arm Type
Experimental
Arm Description
Lyophilized sterile fecal filtrate capsules
Intervention Type
Biological
Intervention Name(s)
Lyophilized fecal microbiota transplant
Intervention Description
15 capsules
Intervention Type
Biological
Intervention Name(s)
Lyophilized sterile fecal filtrate
Intervention Description
15 capsules
Primary Outcome Measure Information:
Title
Resolution of RCDI
Description
Proportion of patients without RCDI
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Resolution of RCDI
Description
Proportion of patients with sustained cure
Time Frame
24 weeks
Title
Serious Adverse Events
Description
Mortality directly attributable to CDI or treatment
Time Frame
8 weeks
Title
Serious Adverse Events
Description
Infection directly attributable to treatment
Time Frame
8 weeks
Title
Minor Adverse Events
Description
Nausea
Time Frame
1 week
Title
Minor Adverse Events
Description
Vomiting
Time Frame
1 week
Title
Minor Adverse Events
Description
Abdominal discomfort
Time Frame
1 week
Title
Difficulty swallowing capsules
Description
Reported by patients as ranging between none, moderate or severe
Time Frame
1 week
Title
Fever
Description
Temperature of >37.8C
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
Ability to provide informed consent
Females and males must agree to effective contraception for the duration of the study
Exclusion Criteria:
Severe or fulminant colitis
Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
Those taking or planning to take an investigational drug within 3 months of enrollment
Chemotherapy or radiation therapy
Oropharyngeal or significant esophageal dysphagia
Ileus or small bowel obstruction
Pregnant or planning to become pregnant within 3 months
Breastfeeding or planning to breastfeed during the trial
Active infection requiring antibiotics
Life expectancy <6 months Those with history of total colectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Kao, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
University of British Columbia
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Mcgill University Health Centre
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
University Of Calgary
City
Calgary
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
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