Allogenic FMT for Bipolar Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bipolar Disorder+2 More
Allogenic FMT - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Bipolar Disorder

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: stool sample collected at Baseline (Visit 2), week 12 and at week 24

Week 24
Change in the MADRS total score from baseline (pre-intervention) to the final visit (week 24).
Changes in the the Clinical Global Impression (CGI) scale
Changes in the the World Health Organization Quality of life (WHOQOL-BREF) rating
Side effects as reported on the Toronto Side Effect Scale (TSES)
Week 24
Changes in fecal Metabolome
Changes in fecal microbiome profile

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Allogenic FMT
1 of 2
Autologous FMT
1 of 2

Active Control

Non-Treatment Group

35 Total Participants · 2 Treatment Groups

Primary Treatment: Allogenic FMT · Has Placebo Group · Phase 2 & 3

Autologous FMT
Biological
PlaceboComparator Group · 1 Intervention: Autologous FMT · Intervention Types: Biological
Allogenic FMT
Biological
ActiveComparator Group · 1 Intervention: Allogenic FMT · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: stool sample collected at baseline (visit 2), week 12 and at week 24

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,370 Previous Clinical Trials
471,837 Total Patients Enrolled
14 Trials studying Bipolar Disorder
1,207 Patients Enrolled for Bipolar Disorder
Valerie TaylorLead Sponsor
1 Previous Clinical Trials
180 Total Patients Enrolled
Valerie Taylor, MD, PhDPrincipal InvestigatorWomen's College Hospital
2 Previous Clinical Trials
260 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18 and 65.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References