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Fecal Microbiota Transplantation for Depression
Phase 2 & 3
Recruiting
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
Participants should be between 18-60 years of age
Have a comorbid diagnosis of IBS including diarrhea predominant IBS (IBS-D), constipation predominant IBS (IBS-C), IBS with mixed bowel habits (IBS-M), or unclassified with IBS (IBS-U) as confirmed by the referring doctor using ROME III criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 13
Awards & highlights
Study Summary
This trial is testing whether a treatment called Fecal Microbiota Transplantation (FMT) is effective, safe, and tolerable for adults with Major Depressive Disorder (MDD) who also have Inflammatory Bowel Syndrome (IBS). The study will also look at whether FMT affects cognitive and neural changes associated with MDD and MDD+IBS.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the study aims to determine the safety of oral FMT, potential side effects may include digestive discomfort, changes in bowel habits, abdominal pain, bloating and possible immune reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
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I have been diagnosed with IBS by my doctor.
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I have tried at least 2 antidepressants without success.
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My depression diagnosis was confirmed by a specialized interview.
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My IBS symptoms are moderate to severe, scoring 175 or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IBS Symptom Severity Scale (IBS-SSS)
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary outcome measures
IBS specific Quality of Life (IBS-QoL)
Toronto Side Effect Scale (TSES)
nuclear magnetic resonance (NMR) spectrometry
Other outcome measures
structural and functional neuroimaging
Trial Design
6Treatment groups
Active Control
Group I: Participants with a confirmed diagnosis MDD who will receive FMT + TAUActive Control1 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 + TAUActive Control1 Intervention
Group III: Healthy ControlsActive Control1 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 TAUActive Control1 Intervention
Group V: Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAUActive Control1 Intervention
Group VI: Participants with a confirmed diagnosis of MDD receiving TAUActive Control1 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.
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Who is running the clinical trial?
Valerie TaylorLead Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Depression
35 Patients Enrolled for Depression
Valerie Taylor, MD, PhDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
115 Total Patients Enrolled
2 Trials studying Depression
115 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that weakens my immune system.I have been taking prebiotics or probiotics for over two weeks in the last three months.My IBS symptoms are moderate to severe, scoring 175 or more.I am between 18 and 60 years old.I have been taking NSAIDs, antibiotics, or iron supplements regularly for the last 3 months.I have been diagnosed with IBS by my doctor.I have been diagnosed with IBS by my doctor.I have tried at least 2 antidepressants without success.I have been diagnosed with Schizophrenia, schizoaffective, or bipolar disorder.My depression diagnosis was confirmed by a specialized interview.My IBS symptoms are moderate to severe, scoring 175 or more.I have been diagnosed with IBS by my doctor.My IBS symptoms are moderate to severe, scoring 175 or more.I have tried at least 2 antidepressants without success.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with a confirmed diagnosis MDD who will receive FMT + TAU
- Group 2: Participants with a confirmed diagnosis of MDD + IBS assigned to receive FMT + TAU
- Group 3: Healthy Controls
- Group 4: Participants with a confirmed diagnosis IBS only receiving TAU
- Group 5: Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAU
- Group 6: Participants with a confirmed diagnosis of MDD receiving TAU
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05174273 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being sought for this experiment?
"The trial is still recruiting patients, as seen on clinicaltrials.gov. This page was originally created on April 6th, 2022 and was last updated on May 18th, 2022."
Answered by AI
Is the age limit for participants in this experiment over eighty years old?
"The age requirements to take part in this specific clinical trial are between 18-60 years old. There are 584 other trials for minors and 2028 for seniors."
Answered by AI
Who else is applying?
What state do they live in?
Washington
California
Pennsylvania
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0
3+
What site did they apply to?
University of Calgary, TRW building
Why did patients apply to this trial?
I always wanted to try it out. I would like to find something that works. Trying to help myself and others who suffer with depression.
PatientReceived no prior treatments
In the past I have tried numerous meds that didn't help me . I have a long hx of MDD and IBS. No medication has been useful.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is the study? Where would FT be done? Is this procedure invasive?
PatientReceived no prior treatments
How long to screening visits take? Im unable to travel for study. I am also on many medications for other conditions. Will all my meds be safe to take without drug interactions or any negative side effects?
PatientReceived 2+ prior treatments
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