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Microbiome Therapy

Fecal Transplant for Depression

Phase 2 & 3

Recruiting

Led By Valerie Taylor, MD, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 18-65 years of age: Participants should be at least 18 years old and not older than 65 years at the day of screening

Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47

Must not have

Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease)

Not breastfeeding, pregnant or seeking to get pregnant during the course of this study. Be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (pre-intervention) to the final visit (week 13)

Summary

This trial is testing whether a fecal transplant can help people with depression who haven't responded to other treatments.

Who is the study for?

Adults aged 18-65 with Major Depressive Disorder (MDD) who haven't improved after trying at least two antidepressants can join this trial. They must have a specific depression score (≥19 on the MADRS scale), be on stable antidepressant treatment for 8 weeks, and not use certain medications or have chronic gastrointestinal diseases, immune suppression, or severe psychiatric conditions.

What is being tested?

The trial is testing if swallowing FMT oral capsules is safe and effective for treating Treatment Resistant Depression compared to placebo capsules. Participants are randomly given either the real treatment or a placebo to see if there's an improvement in their depression symptoms.

What are the potential side effects?

While the side effects of FMT oral capsules aren't fully known yet, potential risks may include digestive discomfort, allergic reactions to capsule components, and changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with major depressive disorder (MDD).

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I have been diagnosed with major depressive disorder (MDD).

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I have depression that hasn't improved after trying at least two different antidepressants.

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My gastroenterologist confirmed I have IBS-D.

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I am between 18 and 65 years old.

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I have depression that hasn't improved after trying at least two antidepressants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a long-term gut condition like IBD, Crohn's, Ulcerative colitis, or Celiac disease.

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I am not pregnant or breastfeeding and use reliable birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (pre-intervention) to the final visit (week 13)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (pre-intervention) to the final visit (week 13)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (pre-intervention) to the final visit (week 13) 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

Secondary study objectives

GI tolerability of patients with Irritable Bowel Syndrome (IBS)

Side effects as reported on the Toronto Side Effect Scale (TSES)

Other study objectives

To assess the effect of FMT on microbiome profile

To examine imaging changes

changes in inflammatory markers (Blood)

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: FMT capsulesActive Control1 Intervention

Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes. PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that

Group II: Placebo oral CapsulesPlacebo Group1 Intervention

Placebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm.

0 / 9Eligibility criteria met