20 Participants Needed

FMT + SIMBA for Obsessive-Compulsive Disorder

(FOCUSED Trial)

AB
VK
Overseen ByVivek Kumar, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Valerie Taylor
Must be taking: SSRIs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether transferring healthy gut bacteria to people with OCD can help those who don't benefit from current treatments. Researchers will compare traditional methods with a new approach to see how the transplant affects the gut and brain. This technique has a long history and is currently being used to treat various conditions, including digestive disorders.

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.

How does the FMT Capsule treatment for OCD differ from other treatments?

FMT Capsule treatment for OCD is unique because it involves the use of fecal microbiota transplantation (FMT), which is not a standard approach for OCD. This treatment focuses on altering the gut microbiome, which is a novel mechanism compared to traditional therapies like cognitive-behavioral therapy or medications that target brain chemistry.12345

Who Is on the Research Team?

VT

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

I have been on a steady dose of SSRI medication for 3 months.
My current depression medication is not working well enough.
I have been diagnosed with OCD.

Exclusion Criteria

Breastfeeding, pregnant or seeking to get pregnant during the course of this study
I have difficulty swallowing.
I have fewer than 2 bowel movements a week.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FMT capsules as an adjunct treatment to their approved first line OCD medication

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • FMT Capsule
Trial Overview The trial tests fecal microbiota transplantation (FMT) using capsules containing gut bacteria from healthy donors to treat OCD. It explores the connection between gut health and brain function by comparing stool analysis and SIMBA capsule results—a device that samples fluid from the small intestine—to see how FMT might benefit those with OCD.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: FMT capsule + SIMBA CapsuleExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Valerie Taylor

Lead Sponsor

Trials
3
Recruited
240+

Nimble Science Ltd.

Industry Sponsor

Trials
11
Recruited
570+

University of Calgary

Collaborator

Trials
827
Recruited
902,000+

Citations

The Bergen 4-Day OCD Treatment Delivered in a Group Setting: 12-Month Follow-Up. [2020]
Metacognitive Training for Obsessive-Compulsive Disorder: a study protocol for a randomized controlled trial. [2022]
Evidence-based treatment pathways for translational studies in obsessive-compulsive disorders. [2021]
Maximizing remission from cognitive-behavioral therapy in medicated adults with obsessive-compulsive disorder. [2022]
The Bergen 4-Day Treatment (B4DT) for Obsessive-Compulsive Disorder: Outcomes for Patients Treated After Initial Waiting List or Self-Help Intervention. [2020]
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