- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398969
Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI
A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver Coastal Health (VCHRI/VCHA) - Diamond Health Care Centre and Vancouver General Hospital
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Ontario
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Hamilton, Ontario, Canada
- Hamilton Health Sciences
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Hamilton, Ontario, Canada, L8N4A6
- St. Joseph's Hospital
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Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patient inclusion criteria
- 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.
Symptoms of CDI, diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea. Subjects will be required to have laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection where recurrence is defined as return of diarrhea and positive stool test after a period of symptom resolution within 8 weeks of the first episode and has received at least a 10-day course of standard antibiotic therapy.
Patient exclusion criteria
- Planned or actively participating in another clinical trial.
- 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 10E9/L AND temperature > 38.0 oC
- Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
- Presence of colostomy
- Unable to tolerate HBT or enema for any reason.
- Requiring systemic antibiotic therapy for more than 7 days.
- Actively taking Saccharomyces boulardii
- 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.
Donor inclusion
- Able to provide and sign informed consent.
- Able to complete and sign the donor questionnaire
- Able to adhere to fecal transplantation stool collection standard operating procedure.
Donor exclusion
- Tested positive for any of the following: Human Immunodeficiency virus (HIV) 1/2, hepatitis IgM, hepatitis B (HBsAg), hepatitis C antibody, syphilis, human T- lymphotrophic virus (HTLV) 1/II and vancomycin resistant Enterococcus (VRE), methicillin resistant S. aureus (MRSA), Salmonella, Shigella, E.coli O157 H7, Yersinia and Campylobacter.
- Detection of ova, parasites, C. difficile toxin, norovirus, adenovirus, rotavirus on stool examination
- History of any type of active cancer or autoimmune disease
- History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire, appendix B.
- History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
- Receipt of blood transfusion from a country other than Canada in preceding 6 months
- Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
- Receipt of any type of live vaccine within 3 months prior to stool donation
- Ingestion of nut or shell fish 3 days preceding donation if the recipient has known allergies to these food.
- Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the donor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Fresh FMT
Participants in this arm will receive Fresh FMT via rectal administration.
They will be followed for 13 weeks to assess the cure or recurrence of CDI.
All other procedures between the two arms will be identical.
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Participants will receive fresh FMT (supernatant of fecal specimen mixed with water) on day 1.
If cure is not reached at day 5 (+3) a repeat FMT will be performed
Other Names:
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Experimental: Frozen-and-Thawed FMT
Participants in this arm will receive Frozen-and-Thawed FMT via rectal administration.
They will be followed 13 weeks to assess the cure or recurrence of CDI.
All other procedures between the two arms will be identical.
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Participants will receive frozen-and-thawed FMT (supernatant of fecal specimen mixed with water) on day 1.
If cure is not reached at day 5 (+3) a repeat FMT will be performed
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evaluation of the safety of HBT
Time Frame: 13 Weeks post HBT
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Assessment for adverse reactions in each study group by history, physical examination, blood work at baseline, day 12, week 5 and at completion (week 13) of the study period.
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13 Weeks post HBT
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To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT.
Time Frame: 13 Weeks post HBT
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13 Weeks post HBT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the relapse rate of clinical and laboratory evidence of CDI within the 13-week study period in participants treated with fresh HBT in comparison to frozen thawed HBT.
Time Frame: 13 Weeks post HBT
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13 Weeks post HBT
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Assessment of the functional health and well-being of patients
Time Frame: Up to 1 year
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Patients will be asked to fill in the self-administered Health Survey at baseline, week 5, week 13 and 1 year from last HBT
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Up to 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Lee, MD, St. Joseph's Healthcare Hamilton
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDI.HBT.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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