FMT + SIMBA for Obsessive-Compulsive Disorder

(FOCUSED Trial)

Overseen By Vivek Kumar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Valerie Taylor

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Valere Taylor, MD,PhD,FRCPC

Principal Investigator

Professor, Head of Department

Eligibility Criteria

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.

Treatment Details

Interventions

• FMT Capsule (Microbiome Therapy)

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.

Participant Groups

Group I: FMT capsule + SIMBA Capsule Experimental Treatment 1 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.

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+