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

NCT05720793 | Unknown Phase 2

• 1 other identifier: NIM-FMT/OCD-2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; Microbiome; FMT; Gut bacteria

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Reported Adverse events

  0-13 weeks

• Toronto Side Effects Scale (TSES)

  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 Outcomes (7)

• Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))

  0-13 weeks

• Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))

  0-13 weeks

• Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))

  0-13 weeks

• Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))

  0-13 weeks

• OCD symptoms (Y-BOCS)

  0-13 weeks

Study Arms (1)

FMT capsule + SIMBA Capsule

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.

Combination Product: FMT Capsule + SIMBA Capsule

Interventions

FMT Capsule + SIMBA Capsule COMBINATION_PRODUCT

Participants in this arm will receive FMT capsules in addition to their usual treatment. participants will also be administered SIMBA sample collection capsules.

FMT capsule + SIMBA Capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Valerie Taylor: lead
• Nimble Science Ltd.: collaborator
• University of Calgary: collaborator

Study Sites (1)

University of Calgary, TRW building

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Valere Taylor, MD,PhD,FRCPC

  Professor, Head of Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asem Bala, Msc, CCRP

CONTACT

4032107282; asem.bala@ucalgary.ca

Vivek Kumar, MD

CONTACT

403-210-8650; vivek.kumar@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Phd, FRCPC, Professor, Department Head

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 9, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 30, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)