Fecal microbiota transplantation for treating obsessive-compulsive disorder
A Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
This study is testing whether a treatment that involves transferring healthy gut bacteria can help adults with obsessive-compulsive disorder who haven't found relief with regular medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05720793 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) as a treatment for adults with obsessive-compulsive disorder (OCD) who have not responded adequately to standard SSRI medications. The study aims to explore the connection between gut bacteria and brain health, leveraging the potential benefits of FMT to improve OCD symptoms. Participants will receive FMT capsules along with SIMBA capsules, and their gut microbiome will be analyzed to assess changes and outcomes. The trial is designed to provide new insights into alternative treatment options for OCD.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with OCD who have been on a stable dose of SSRI treatment for at least 12 weeks but continue to experience significant symptoms.
Not a fit: Patients with substance use disorders, eating disorders, or other specified psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel treatment option for patients with OCD who do not respond to existing medications.
How similar studies have performed: Previous studies have shown promising results for fecal microbiota transplantation in treating depression, suggesting potential for success in OCD, although this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults who have a primary diagnosis of OCD * on a stable appropriate dose of (SSRI) treatment for at least 12 weeks prior to Baseline * insufficient response to current SSRI treatment indicated by persistence of symptoms. Exclusion Criteria: * Participant meets Diagnostic criteria for substance use, eating disorder, schizophrenia, or schizoaffective disorder * Suicidality * regular intake of antibiotics, prebiotics, or probiotics * Clinically diagnosed with IBD, Crohn's disease, Ulcerative colitis, or Celiac disease * Immune suppression * intestinal obstruction * Oropharyngeal dysphagia or other swallowing disorder * \< 2 bowel movements per week * Breastfeeding, pregnant or seeking to get pregnant during the course of this study
Where this trial is running
Calgary, Alberta
- University of Calgary, TRW building — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Valere Taylor, MD,PhD,FRCPC — Professor, Head of Department
- Study coordinator: Asem Bala, Msc, CCRP
- Email: asem.bala@ucalgary.ca
- Phone: 4032107282
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.