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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

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

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

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 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.

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