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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 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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoOTHER

1,468 Previous Clinical Trials

484,484 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial for new participants?

"Unfortunately, this study is not presently looking for new patients according to the information available on clinicaltrials.gov. This particular trial was initially posted on 1/1/2018 and last edited on 4/27/2022. However, there are 1295 other trials actively recruiting right now."

Answered by AI

How can I sign up to participate in this experiment?

"To be eligible for this study, participants must be between 18-65 years old, have bipolar disorder, and meet the following additional requirements: they must be an outpatient, have been on a stable first line treatment for BD depression at an adequate dose for at least 8 weeks prior to study entry, and suffer from a current depressive episode (Montgomery-Åsberg Depression Rating Scale (MADRS) score at screening and baseline of ≥ 12)."

Answered by AI

Is this study only for young adults, or can people of any age participate?

"The age limit to participate in this trial is 18-65. Out of the 1254 clinical trials registered on www.clinicaltrials.gov, 205 are for people under 18 and 949 are for seniors."

Answered by AI