FMT + SIMBA for Obsessive-Compulsive Disorder
(FOCUSED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for people with obsessive-compulsive disorder (OCD) who haven't found relief with current medications. Researchers are studying whether a fecal transplant, using healthy bacteria from a donor, might help manage OCD symptoms. They use a new capsule technology called FMT Capsule to examine changes in the gut. Participants must have OCD as their primary condition and continue to experience symptoms despite using an SSRI (a common OCD medication) for at least 12 weeks. This trial could offer new hope for those struggling with OCD when typical treatments haven't worked. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, giving participants a chance to contribute to potentially groundbreaking OCD treatment advancements.
Will I have to stop taking my current medications?
The trial requires participants to be on a stable dose of an SSRI (a type of antidepressant) for at least 12 weeks before starting. However, you cannot regularly take antibiotics, prebiotics, or probiotics during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that Fecal Microbiota Transplantation (FMT) has promising results for treating various mental illnesses, including depression. This suggests that FMT might also help with conditions like OCD. Research has shown that FMT is generally well-tolerated, with few side effects. For example, a trial using FMT capsules found them safe for people with OCD. Some participants might experience mild side effects like an upset stomach, but these are usually temporary.
There is less direct information about the SIMBA system. However, as part of a research trial, researchers closely monitor any potential risks. The trial's phase indicates that the treatment has already passed initial safety checks, suggesting it is safe enough for further testing in people with OCD.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for Obsessive-Compulsive Disorder (OCD), which typically include medications like SSRIs and behavioral therapies, the FMT Capsule introduces a novel approach by using fecal microbiota transplantation. This treatment is unique because it leverages the gut-brain axis, aiming to influence mental health through gut microbiota. Researchers are excited about this because it represents a shift from targeting brain chemistry alone to potentially modulating the gut environment, opening new avenues for treating OCD.
What evidence suggests that this trial's treatments could be effective for OCD?
Research has shown that fecal microbiota transplantation (FMT) could help treat mental health issues. For example, studies have found that FMT can greatly reduce symptoms in people with depression. This is important because OCD is related to other mental health disorders, suggesting FMT might also help those with OCD. In this trial, participants will receive FMT capsules as an adjunct treatment alongside an approved first-line treatment for OCD. The process transfers healthy gut bacteria, which is believed to improve brain function. Early results in other conditions suggest that FMT could be a promising new option for people who haven't responded to traditional OCD treatments.13456
Who Is on the Research Team?
Valere Taylor, MD,PhD,FRCPC
Principal Investigator
Professor, Head of Department
Are You a Good Fit for This Trial?
This trial is for adults with OCD who haven't had enough improvement from their current SSRI treatment. They must have been on a stable dose for at least 12 weeks and not be suicidal or diagnosed with certain digestive diseases like IBD, Crohn's, Ulcerative colitis, or Celiac disease. They can't be immune-suppressed, pregnant, breastfeeding, planning to get pregnant during the study, regularly taking antibiotics/prebiotics/probiotics, have swallowing disorders or meet criteria for substance use/eating disorder/schizophrenia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FMT capsules as an adjunct treatment to their approved first line OCD medication
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FMT Capsule
Find a Clinic Near You
Who Is Running the Clinical Trial?
Valerie Taylor
Lead Sponsor
Nimble Science Ltd.
Industry Sponsor
University of Calgary
Collaborator