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

Sponsor

Valerie Taylor (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05720793

Collaborator

Nimble Science Ltd. (Industry), University of Calgary (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Combination Product: FMT Capsule + SIMBA Capsule	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adverse Events [0-13 weeks]
Reported Adverse events
Toronto Side Effects Scale (TSES) [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.

Secondary Outcome Measures

Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS)) [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.
Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7)) [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
Global function/overall improvement (Positive and Negative Affect Schedule (PANAS)) [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.
Global function/overall improvement (Patient Health Questionnaire-9(PHQ9)) [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.
OCD symptoms (Y-BOCS) [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
OCD symptoms (TOCS) [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.
Next generation fecal, Urine, Blood and saliva sequencing [0-13 weeks]
analysis of Fecal, urine, blood and saliva samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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