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Microbiome Therapy

FMT + SIMBA for Obsessive-Compulsive Disorder (FOCUSED Trial)

Phase 2

Recruiting

Led By Valere Taylor, MD,PhD,FRCPC

Research Sponsored by Valerie Taylor

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-13 weeks

Awards & highlights

FOCUSED Trial Summary

This trial is studying if gut bacteria from healthy donors can help people with OCD. It will use stool analysis and SIMBA capsules to measure changes in the gut microbiome.

Who is the study for?

This trial is for adults with OCD who haven't had enough improvement from their current SSRI treatment. They must have been on a stable dose for at least 12 weeks and not be suicidal or diagnosed with certain digestive diseases like IBD, Crohn's, Ulcerative colitis, or Celiac disease. They can't be immune-suppressed, pregnant, breastfeeding, planning to get pregnant during the study, regularly taking antibiotics/prebiotics/probiotics, have swallowing disorders or meet criteria for substance use/eating disorder/schizophrenia.Check my eligibility

What is being tested?

The trial tests fecal microbiota transplantation (FMT) using capsules containing gut bacteria from healthy donors to treat OCD. It explores the connection between gut health and brain function by comparing stool analysis and SIMBA capsule results—a device that samples fluid from the small intestine—to see how FMT might benefit those with OCD.See study design

What are the potential side effects?

While specific side effects are not listed here due to the novel nature of this intervention in treating OCD via FMT capsules plus SIMBA capsules; potential risks may include gastrointestinal discomforts such as bloating or cramps.

FOCUSED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-13 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Toronto Side Effects Scale (TSES)

Secondary outcome measures

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

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

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

+4 more

FOCUSED Trial Design

1Treatment groups

Experimental Treatment

Group I: FMT capsule + SIMBA CapsuleExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Valerie TaylorLead Sponsor

2 Previous Clinical Trials

215 Total Patients Enrolled

Nimble Science Ltd.Industry Sponsor

6 Previous Clinical Trials

465 Total Patients Enrolled

University of CalgaryOTHER

792 Previous Clinical Trials

869,134 Total Patients Enrolled

2 Trials studying Obsessive-Compulsive Disorder

201 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

FMT Capsule (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05720793 — Phase 2

Obsessive-Compulsive Disorder Research Study Groups: FMT capsule + SIMBA Capsule

Obsessive-Compulsive Disorder Clinical Trial 2023: FMT Capsule Highlights & Side Effects. Trial Name: NCT05720793 — Phase 2

FMT Capsule (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720793 — Phase 2

Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05720793 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential adverse effects could arise from the combination of FMT capsule and SIMBA Capsule?

"The existing evidence on FMT capsule + SIMBA Capsule's safety is sufficient to warrant a score of 2. This Phase 2 trial has not yet produced any data regarding the medication's efficacy, but there are multiple studies indicating its safety profile."

Answered by AI

Does the study requirements include elderly participants aged 85 and over?

"This clinical trial has a narrow age range of 18 to 65. However, there are additional studies dedicated specifically for those under 18 and over 65 respectively; 20 trials and 67 trials in total."

Answered by AI

Are new participants still being sought for this scientific endeavor?

"As per clinicaltrials.gov, the recruitment for this medical trial has closed since the last changes made to it were on February 7th 2023. Nonetheless, there are currently 106 other trials actively searching for participants."

Answered by AI

What are the desired outcomes of this experiment?

"The primary outcome metric for this Nimble Science Ltd.-sponsored study, evaluated over a 0-13 week period of time, is the Toronto Side Effects Scale (TSES). Additionally, secondary assessments will be conducted to gauge Global function/overall improvement; these include The General Anxiety Disorder-7 scale (GAD-7), Positive and Negative Affect Schedule (PANAS) as well as Patient Health Questionnaire-9(PHQ9)."

Answered by AI

Am I eligible to enroll in this clinical experiment?

"This clinical trial is enrolling 20 individuals between the ages of 18 and 65 who have been diagnosed with Obsessive Compulsive Disorder (OCD). To be eligible, patients must also meet the following requirements: a confirmed OCD diagnosis, at least 12 weeks of SSRI treatment prior to baseline assessment, and evidence that their current medication has not adequately managed symptoms."

Answered by AI

Who else is applying?

What state do they live in?

New Jersey

Wisconsin

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What site did they apply to?

University of Calgary, TRW building

Why did patients apply to this trial?

I’ve tried more than 3 drugs, therapy, and TMS. I still have severe OCD and want to keep trying to find an effective treatment.

PatientReceived 2+ prior treatments

I've been interested in trying FMT for a while. I've tried many therapies including several ssris, snris, antipsychotics, glutamate modulating drugs, I.V. Anafranil, etc...

PatientReceived 2+ prior treatments

I've been wanting to try fmt for a long time. I think it might help my OCD. My severe and hard to treat OCD that is. I've tried several SSRIs and SNRIs, antipsychotics old and new, TMS, IV Anafranil, ERP, CBT, and even DBS (Deep Brain Stimulation, and more.

PatientReceived no prior treatments