Please sign in to follow a disease.
Could a poop pill lift depression and soothe IBS?
NCT ID NCT05174273
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking fecal microbiota transplantation (FMT) pills can improve symptoms of major depressive disorder (MDD) and irritable bowel syndrome (IBS). About 133 adults with MDD, with or without IBS, will either receive FMT or continue their usual treatment. Researchers will measure changes in depression and IBS severity over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
133 people
The number who actually took part.
- Started
-
Apr 2022
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Between 18-60 years of age: Participants should be at least 18 years old and not older than 60 years at the day of screening 2. Have a primary diagnosis of MDD as assessed/confirmed by the M.I.N.I. International Neuropsychiatric Interview (MINI) 3. Have had a well-documented inadequate response to at least 2 approved antidepressants 4. A MADRS score of ≥ 19 at screening and visit 2a 5. Have a comorbid diagnosis of IBS. IBS patients can include any of the following: 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 6. Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS) Exclusion Criteria: 1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)\[1\] Criteria for the following conditions according to the M.I.N.I: 1. Substance Use Disorder within the last 3 months. \*(Criteria should include Alcohol and non-alcohol substances except Cannabis) 2. Moderate or severe substance use disorder for Cannabis use the last 3 months 3. Active Anorexia Nervosa or Bulimia nervosa 4. Schizophrenia, schizoaffective or bipolar disorder 5. Active suicidality 2. Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the three (3) months prior to study entry 3. Use of prebiotics or probiotics for medical purposes for more than two (2) weeks within the last three (3) months 4. Conditions causing immunosuppression 5. Women who are breastfeeding, pregnant or seeking to get pregnant during the course of this study. Not using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Irritable bowel syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Calgary, TRW building
Calgary, Alberta, T2N 4Z6, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an antipsychotic restore feelings in people with depression?
- Can intense brain zaps lift depression? scientists track blood flow in real time
- Can an ancient herbal capsule boost antidepressant power?
- Can talk therapy keep Esketamine's relief going?
- Can brisk walking boost antidepressant results?
- Scientists probe brain's reward system in mental illness