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FOCUSEDA Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder

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What is being tested

FMT Capsule + SIMBA Capsule

Combination Product
Who is being recruted

Anxiety Disorders

+ Mental Disorders

+ Obsessive-Compulsive Disorder

From 18 to 65 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorValerie Taylor
Study ContactAsem Bala, Msc, CCRPMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2023

Actual date on which the first participant was enrolled.

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.

Official TitleA Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
NCT05720793
Principal SponsorValerie Taylor
Study ContactAsem Bala, Msc, CCRPMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersMental DisordersObsessive-Compulsive Disorder

Criteria

3 inclusion criteria required to participate
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.

9 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Calgary, TRW building

Calgary, CanadaOpen University of Calgary, TRW building in Google Maps
SuspendedOne Study Center
FOCUSED | A Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder | PatLynk