A Clinical Trial of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder (FOCUSED)

November 27, 2023 updated by: Valerie Taylor

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Immune suppression
  • intestinal obstruction
  • Oropharyngeal dysphagia or other swallowing disorder
  • < 2 bowel movements per week
  • Breastfeeding, pregnant or seeking to get pregnant during the course of this study

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FMT capsule + SIMBA Capsule
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.
Combination product: FMT Capsule + SIMBA Capsule
Participants in this arm will receive FMT capsules in addition to their usual treatment. participants will also be administered SIMBA sample collection capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 0-13 weeks
Reported Adverse events
0-13 weeks
Toronto Side Effects Scale (TSES)
Time Frame: 0-13 weeks
Changes in the Toronto Side Effects Scale (TSES). TSES a 32-item instrument used to evaluate the incidence, frequency, and severity of the central nervous system (CNS), gastrointestinal (GI), and sexual side effects.
0-13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))
Time Frame: 0-13 weeks
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS). is a 16-item questionnaire that rates depression symptoms via self-assessment. Toral score is calculated but summing the scores of each of the 16 different questions. 0-5 Normal, 6-10 mild depression, 11-15 Moderate depression, 16-20 Severe depression and >21 is considered very severe depression.
0-13 weeks
Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))
Time Frame: 0-13 weeks
The General Anxiety Disorder-7 scale (GAD-7). The 7-item tool is used to screen and assess for generalized anxiety. Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety and Score greater than 15: Severe Anxiety
0-13 weeks
Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))
Time Frame: 0-13 weeks
Positive and Negative Affect Schedule (PANAS). The PANAS is a self-report questionnaire that consists of two 10-item scales and measures both positive and negative emotions for participants. The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. higher score indicates more positive or negative affect respectively.
0-13 weeks
Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))
Time Frame: 0-13 weeks
Patient Health Questionnaire-9(PHQ9). The PHQ9 is used for screening and measuring the severity of depressive symptoms. The total score is the sum the numbers of all the checked responses under each heading. Cut off scores are: 0 - 4 None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe and 20 - 27 Severe.
0-13 weeks
OCD symptoms (Y-BOCS)
Time Frame: 0-13 weeks
Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Total scores range from 0 to 40. 0-7 indicates subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms
0-13 weeks
OCD symptoms (TOCS)
Time Frame: 0-13 weeks
Toronto Obsessive-Compulsive Scale (TOCS). TOCS is a 21 item self-reported questionnaire that assesses several major symptom dimensions in OCD. A total score is calculated by adding each score of the 21 items, and dimension scores are calculated by averaging the sum of item scores within each dimension.
0-13 weeks
Next generation fecal, Urine, Blood and saliva sequencing
Time Frame: 0-13 weeks
analysis of Fecal, urine, blood and saliva samples
0-13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valerie Taylor

Collaborators

University of Calgary
Nimble Science Ltd.

Investigators

  • Principal Investigator: Valere Taylor, MD,PhD,FRCPC, Professor, Head of Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIM-FMT/OCD-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will also share our results via the "Gut Microbiota for Health Experts exchange", an online community where experts in this field share news, innovation and information on topics pertaining to the gut microbiota (www.gutmicrobiotaforhealth.com). This organization has over 10 000 online members and a large social media presence. Manuscripts will be published in scientific journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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