Fecal Microbiota Transplantation for Depression

Recruiting in Palo Alto (17 mi)

Overseen by Valerie Taylor, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Valerie Taylor

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is a phase 2/3 open-label controlled trial (CT) in which adults with Major Depressive Disorder (MDD) and adults who have MDD plus comorbid Inflammatory Bowel Syndrome (IBS) will be assigned to either receive oral Fecal Microbiota Transplantation (FMT) or to continue with the treatment they are currently receiving in a Treatment As Usual (TAU) arm. An IBS alone group receiving TAU will be recruited as a clinical control group. The primary goals of this study are to determine effectiveness, safety and tolerability of oral FMT in adults with MDD and in MDD who have comorbid IBS. Additional goals are to characterize patterns and progressions of cognitive and neural correlates associated with MDD and with MDD + IBS and to determine if they improve with FMT. It is known that both, individuals with MDD and those with MDD and IBS show cognitive alterations as well as changes in neural structures, but this study is designed to see if those are changed with treatment response to FMT."

Research Team

Valerie Taylor, MD, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

Adults aged 18-60 with Major Depressive Disorder (MDD) and/or Irritable Bowel Syndrome (IBS), who haven't responded well to at least two antidepressants, can join. They must have moderate-to-severe IBS symptoms confirmed by a doctor. People with substance use disorders, eating disorders, schizophrenia-related conditions, active suicidality or those on certain medications like NSAIDs cannot participate.

Inclusion Criteria

I am between 18 and 60 years old.

I have been diagnosed with IBS by my doctor.

I have tried at least 2 antidepressants without success.

Exclusion Criteria

I have a condition that weakens my immune system.

Participant has moderate or severe substance use disorder for Cannabis use in the last 3 months

Participant has active Anorexia Nervosa or Bulimia nervosa

Treatment Details

Interventions

• Fecal Microbiota Transplantation (Other)

Trial Overview The trial is testing if swallowing pills containing fecal matter from healthy donors (Fecal Microbiota Transplantation or FMT) can improve depression and cognitive function in people with MDD alone or combined with IBS compared to their usual treatments.

Participant Groups

Group I: Participants with a confirmed diagnosis MDD who will receive FMT + TAU Active Control 1 Intervention

Eligible and consenting patients will be assigned 1:1 to receive either FMT from a healthy donor or continuing on their usual medication for MDD, i.e., treatment as usual (TAU). This arm will be assigned to receive FMT provided by healthy donors.

Group II: Participants with a confirmed diagnosis of MDD + IBS assigned to receive FMT + TAU Active Control 1 Intervention

Group III: Healthy Controls Active Control 1 Intervention

Data from healthy comparison (HC) participants will be drawn from another completed research study. Healthy comparison participants who will best match the patient population enrolled in the current trial and who consented to data sharing will be selected.

Group IV: Participants with a confirmed diagnosis IBS only receiving TAU Active Control 1 Intervention

Group V: Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAU Active Control 1 Intervention

Group VI: Participants with a confirmed diagnosis of MDD receiving TAU Active Control 1 Intervention

Eligible and consenting patients will be assigned 1:1 to receive either FMT from a healthy donor or continuing on their usual medication for MDD, i.e., treatment as usual (TAU). This arm will continue to receive their usual anti-depressant.

Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

🇪🇺 Approved in European Union as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)
• Other gastrointestinal disorders

🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Calgary, TRW building Calgary, Canada

Who Is Running the Clinical Trial?

Valerie Taylor

Lead Sponsor

Trials

3

Patients Recruited

240+

References