FMT + SIMBA for Obsessive-Compulsive Disorder

(FOCUSED Trial)

Overseen By Vivek Kumar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Valerie Taylor

Must be taking: SSRIs

Must not be taking: Antibiotics, Prebiotics, Probiotics

Disqualifiers: Substance use, Schizophrenia, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

20 Participants Needed

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.

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. ^{1 2 3 4 5}

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.

Timeline

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

Treatment Details

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.

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Bergen 4-Day OCD Treatment Delivered in a Group Setting: 12-Month Follow-Up. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Metacognitive Training for Obsessive-Compulsive Disorder: a study protocol for a randomized controlled trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence-based treatment pathways for translational studies in obsessive-compulsive disorders. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Maximizing remission from cognitive-behavioral therapy in medicated adults with obsessive-compulsive disorder. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Bergen 4-Day Treatment (B4DT) for Obsessive-Compulsive Disorder: Outcomes for Patients Treated After Initial Waiting List or Self-Help Intervention. [2020]