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Could gut bacteria hold the key to childhood OCD?

NCT ID NCT06754319

Knowledge-focused Sponsor: Shanghai Mental Health Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study investigates how the gut-brain axis—the communication network between gut bacteria and the brain—might be involved in pediatric obsessive-compulsive disorder (OCD). Researchers will compare gut microbiome, blood metabolites, brain imaging, and EEG data from children with OCD, those with OCD plus tic disorder, and healthy controls, before and after treatment with SSRIs. The goal is to uncover biological clues that could lead to new treatment targets and better strategies for managing OCD in young people.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selective serotonin reuptake inhibitors (SSRIs) — a standard class of antidepressants used to treat OCD.
What this could lead to
If successful, this could reveal how the gut-brain axis contributes to pediatric OCD, potentially leading to new biomarkers or treatment targets that improve care for children with this condition.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test whether any new therapy works. The findings may be complex and require further validation before they can influence clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Drug-naïve or drug-free pediatric patients with OCD, drug-naïve or drug-free pediatric OCD patients comorbid with TD, and healthy control.

Ages

7 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

We recruited outpatient children and adolescents with OCD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (4th edition). The following inclusion and exclusion criteria were also applied: Inclusion Criteria: (1) 7-17 years old, (2) Y-BOCS score ≥16, (3) with or without a history of TD, (4) Drug-naïve or drug-free for 8 weeks, (5) Wechsler IQ score ≥ 80. Exclusion Criteria: * History of serious medical, neurological illness or other psychotic disorders other than OCD (tic disorder excepted). * Previous exposure to cognitive behavioral therapy (CBT) for OCD or TD. * serious suicide risk. * Has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within the past 8 weeks. * Has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus. * Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

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Conditions

The condition(s) this trial relates to.

obsessive-compulsive disorder tic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obsessive compulsive disorder Tic disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Mental Health Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

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