Effects of Fecal Microbiota Transplantation on Depression and IBS
Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome
This study is testing if a new treatment using fecal microbiota transplantation can help adults with depression, with or without irritable bowel syndrome, feel better compared to their usual care.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05174273 on ClinicalTrials.gov |
What this trial studies
This phase 2/3 open-label controlled trial investigates the effects of oral Fecal Microbiota Transplantation (FMT) in adults diagnosed with Major Depressive Disorder (MDD), both with and without comorbid Irritable Bowel Syndrome (IBS). Participants will be assigned to receive FMT or continue their current treatment in a Treatment As Usual (TAU) group. The study aims to evaluate the effectiveness, safety, and tolerability of FMT, as well as to explore cognitive and neural changes associated with MDD and MDD + IBS. A separate IBS-only group receiving TAU will serve as a clinical control. The study seeks to determine if FMT can improve cognitive alterations and neural structures in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with a primary diagnosis of Major Depressive Disorder and a documented inadequate response to at least two approved antidepressants, particularly those with comorbid Irritable Bowel Syndrome.
Not a fit: Patients who do not have Major Depressive Disorder or those with other psychiatric conditions that meet DSM-5 criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for patients suffering from Major Depressive Disorder and IBS, potentially improving their mental health and quality of life.
How similar studies have performed: While the use of Fecal Microbiota Transplantation is a novel approach in this context, preliminary studies have shown promise in similar applications, though this specific combination of MDD and IBS is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Calgary, Alberta
- University of Calgary, TRW building — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Valerie Taylor, MD, PhD — University of Calgary
- Study coordinator: Stefanie Hassel, PhD
- Email: shassel@ucalgary.ca
- Phone: 4032106430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.