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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the MADRS total score

Secondary outcome measures

GI tolerability of patients with Irritable Bowel Syndrome (IBS)

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

Other outcome measures

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,074 Total Patients Enrolled

31 Trials studying Depression

10,560 Patients Enrolled for Depression

Cumming school of medicineUNKNOWN

The W. Garfield Westin FoundationUNKNOWN

Media Library

FMT oral Capsules (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04805879 — Phase 2 & 3

Depression Research Study Groups: FMT capsules, Placebo oral Capsules

Depression Clinical Trial 2023: FMT oral Capsules Highlights & Side Effects. Trial Name: NCT04805879 — Phase 2 & 3

FMT oral Capsules (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04805879 — Phase 2 & 3

Frequently Asked Questions

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

Is this research project accessible to elderly patients?

"The age bracket for potential participants in this clinical trial are individuals who are over 18 but younger than 65."

Answered by AI

Does this research still have room for more participants?

"The trial, which was posted on March 4th 2021 and updated December 13th 2021 according to clinicaltrials.gov, is looking for more participants."

Answered by AI

How many people are eligible to participate in this experiment?

"Yes, the trial is still open and recruiting patients. The clinical trial was first posted on March 4th 2021 and the most recent update was on December 13th 2021. Eighty participants are needed for this study which is taking place at a single site."

Answered by AI

How can I become involved in this clinical trial?

"This study is looking for 80 individuals suffering from depression that meet the age criteria of 18-65. Furthermore, these applicants must also have a MADRS score ≥ 19 at screening and visit 2. For participants that will be included in the IBS-D cohort, they should have a confirmed diagnosis of IBS-D from a referring gastroenterologist."

Answered by AI