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Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder
Phase 2 & 3
Waitlist Available
Led By Valerie Taylor, MD, PhD
Research Sponsored by Valerie Taylor
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stool sample collected at baseline (visit 2), week 12 and at week 24
Summary
This trial is testing whether transferring healthy gut bacteria to adults with bipolar disorder depression can improve their mental health. The idea is that healthier gut bacteria can help balance the gut microbiome and reduce symptoms of depression and anxiety. The study is the first of its kind to evaluate the safety and effectiveness of this microbial therapy for major depressive disorder.
Eligible Conditions
- Depression, Bipolar Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ stool sample collected at baseline (visit 2), week 12 and at week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stool sample collected at baseline (visit 2), week 12 and at week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the MADRS total score from baseline (pre-intervention) to the final visit (week 24).
Secondary study objectives
Changes in fecal Metabolome
Changes in fecal microbiome profile
Changes in the the Clinical Global Impression (CGI) scale
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Allogenic FMTActive Control1 Intervention
Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) from a healthy, screened individual with no personal or family history of an Axis 1 disorder.
Group II: Autologous FMTPlacebo Group1 Intervention
Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) by re-infusion of their own feces donated earlier in the study.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoOTHER
1,527 Previous Clinical Trials
503,511 Total Patients Enrolled
Valerie TaylorLead Sponsor
2 Previous Clinical Trials
200 Total Patients Enrolled
Valerie Taylor, MD, PhDPrincipal InvestigatorWomen's College Hospital
2 Previous Clinical Trials
260 Total Patients Enrolled