What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). SSRIs can cause side effects such as nausea, headache, sleep disturbances, and sexual dysfunction. Cognitive-behavioral therapy generally has fewer side effects but can be emotionally challenging. Treatments that alter gut microbiota, like fecal microbiota transplantation (FMT), are being explored for OCD. Known side effects of FMT include gastrointestinal symptoms such as diarrhea, abdominal cramping, and, in rare cases, infections. More research is needed to fully understand the safety and efficacy of FMT for OCD.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, and sertraline, as well as the tricyclic antidepressant clomipramine. These medications help to reduce the symptoms of OCD by increasing serotonin levels in the brain. While there are no FDA-approved treatments specifically targeting gut microbiota for OCD, emerging research, such as the trial on fecal microbiota transplantation, is exploring this novel approach due to the known link between gut bacteria and brain function.

What other types of research exist?

Promising novel alternatives to fecal transplant for OCD treatment in 2024 include deep brain stimulation (DBS) and pharmacological augmentations such as memantine, riluzole, and minocycline. DBS is an investigational, neurosurgical treatment that has shown promising results in preliminary trials but is invasive and should be considered within clinical trials. Pharmacological augmentations have shown some efficacy in treatment-resistant OCD cases.

← Back to Search

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

No Placebo-Only Group

Summary

This trial is testing whether transferring healthy gut bacteria to people with OCD can help those who don't benefit from current treatments. Researchers will compare traditional methods with a new approach to see how the transplant affects the gut and brain. This technique has a long history and is currently being used to treat various conditions, including digestive disorders.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Toronto Side Effects Scale (TSES)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacotherapy, cognitive-behavioral therapy (CBT), deep brain stimulation (DBS), and fecal microbiota transplantation (FMT). Pharmacotherapy typically involves selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), which increase serotonin levels in the brain to help reduce OCD symptoms. CBT, particularly exposure and response prevention, helps patients confront and reduce their obsessions and compulsions through structured behavioral techniques. DBS is an invasive procedure that involves implanting electrodes in the brain to modulate neural circuits associated with OCD. FMT, a newer approach, aims to alter the gut microbiota by transplanting fecal matter from healthy donors, based on the emerging understanding of the gut-brain axis and its potential role in psychiatric conditions like OCD. This matters for OCD patients as it opens up new avenues for treatment, especially for those who do not respond to traditional therapies.

Natural compulsive-like behaviour in the deer mouse (Peromyscus maniculatus bairdii) is associated with altered gut microbiota composition.Changes in gut microbiota during development of compulsive checking and locomotor sensitization induced by chronic treatment with the dopamine agonist quinpirole.