Clinical trial NCT05720793: A Clinical Trial of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
Official title: A Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Microbiome
FMT
Gut bacteria
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Nimble Science Ltd.
name: University of Calgary
First posted: 2023-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 0-13 weeks
measure: Toronto Side Effects Scale (TSES)
timeFrame: 0-13 weeks
Secondary outcomes:
measure: Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))
timeFrame: 0-13 weeks
measure: Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))
timeFrame: 0-13 weeks
measure: Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))
timeFrame: 0-13 weeks
measure: Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))
timeFrame: 0-13 weeks
measure: OCD symptoms (Y-BOCS)
timeFrame: 0-13 weeks
measure: OCD symptoms (TOCS)
timeFrame: 0-13 weeks
measure: Next generation fecal, Urine, Blood and saliva sequencing
timeFrame: 0-13 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, TRW building
state: Alberta
Study officials:
affiliation: Professor, Head of Department
name: Valere Taylor, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
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