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Allogenic FMT for Depression, 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
Awards & highlights

Study Summary

This trial is testing whether or not a fecal microbiota transplant, or transferring gut bacteria from a healthy donor to a patient, can help treat symptoms of bipolar depression.

Eligible Conditions
  • Depression, Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stool sample collected at baseline (visit 2), week 12 and at week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and stool sample collected at baseline (visit 2), week 12 and at week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the MADRS total score from baseline (pre-intervention) to the final visit (week 24).
Secondary outcome measures
Changes in fecal Metabolome
Changes in fecal microbiome profile
Changes in the the Clinical Global Impression (CGI) scale
+2 more

Trial 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
1,483 Previous Clinical Trials
486,487 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
~5 spots leftby Jun 2025
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