Recruiting
Phase 2

Fecal Microbiota Transplantation

Sponsor:

Valerie Taylor

Code:

NCT05720793

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

FMT Capsule + SIMBA Capsule

Study Details

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

Study ID

NCT05720793

Start date

Jun 1, 2023

Status verified date

Nov, 2023

Completion date

Aug 30, 2024

Anticipated

Primary completion date

Mar 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Adverse Events [ Time Frame: 0-13 weeks ]
  • Toronto Side Effects Scale (TSES) [ Time Frame: 0-13 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Calgary, TRW building

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Asem Bala, MSc

asem.bala@ucalgary.ca

More Information

Sponsor

Valerie Taylor

Last update posted

Nov 30, 2023

Last verified

Nov, 2023

Keywords

  • OCD
  • Microbiome
  • FMT
  • Gut bacteria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Valerie Taylor on 2023-11-30.