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Microbiota Restoration
Open Label Lyophilized Fecal Microbiota Transplantation for Clostridium Difficile Infection
N/A
Waitlist Available
Led By Christine Lee, MD
Research Sponsored by Vancouver Island Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks from last fmt
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Clostridium Difficile Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks from last fmt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks from last fmt
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open Label Lyophilized Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Eligible participants with history of recurrent or refractory CDI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lyophilized Fecal Microbiota Transplantation
2015
N/A
~160
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Who is running the clinical trial?
Vancouver Island Health AuthorityLead Sponsor
16 Previous Clinical Trials
4,492 Total Patients Enrolled
Christine Lee, MDPrincipal InvestigatorVancouver Island Health Authority
6 Previous Clinical Trials
3,645 Total Patients Enrolled
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