A Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Valerie Taylor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
Obsessive-compulsive disorder (OCD) is a psychiatric condition marked by recurrent intrusive thoughts (obsessions) and ritualistic behaviors aimed at reducing distress (compulsions). While there exist a number of medications to treat this illness, half of those who need them either do not respond or can not tolerate current medications because of side effects. Therefore, there is an urgent need to develop new ways to treat this illness. One of the areas being explored as a potential option is based on what is now known as a strong link between the bacteria that live in our gut and the brain. Research has shown that a fecal transplant of the gut bacteria from healthy donors is able to improve health outcomes for people with depression and the investigators now want to expand this into OCD, given a known link between this condition and bacterial infection. To do this the investigators will use both the standard methods of bacterial identification via stool analysis, which looks at large bowel changes, and compare it to the Small Intestine Microbiome Aspiration (SIMBA) system, a small capsule that when swallowed allows a fluid sample to be collected from the participants' small intestine. This work will help the investigators assess the benefits of fecal transplant in OCD, and more importantly, identify how transplant changes the system, utilizing a novel technology to move the field forward.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
FMT capsule + SIMBA Capsule
adults with OCD who are being treated with an approved first line treatment for OCD medication will be assigned to receive FMT capsules as an adjunct treatment.
Intervention: FMT Capsule + SIMBA Capsule (Combination Product)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 0-13 weeks
Reported Adverse events
Toronto Side Effects Scale (TSES)
Time Frame: 0-13 weeks
Changes in the Toronto Side Effects Scale (TSES). TSES a 32-item instrument used to evaluate the incidence, frequency, and severity of the central nervous system (CNS), gastrointestinal (GI), and sexual side effects.
Secondary Outcomes
- Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))(0-13 weeks)
- Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))(0-13 weeks)
- OCD symptoms (Y-BOCS)(0-13 weeks)
- Next generation fecal, Urine, Blood and saliva sequencing(0-13 weeks)
- OCD symptoms (TOCS)(0-13 weeks)
- Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))(0-13 weeks)
- Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))(0-13 weeks)
Investigators
Valerie Taylor
MD, Phd, FRCPC, Professor, Department Head
University of Calgary