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Gut-Brain link under microscope in new mental health study

NCT ID NCT07634458

Knowledge-focused Sponsor: Neurobiologix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will examine whether certain genes related to serotonin are linked to gut bacteria that process tryptophan in adults with depression, anxiety, PTSD, or panic disorder. Thirty participants will provide saliva and stool samples from home. The goal is to gather information for future research, not to test a treatment.

What this could mean

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

What this could lead to
If successful, this study could identify genetic and microbial patterns that guide future treatments for mental health conditions.
What could go wrong
This is a very small, early-stage observational study with only 30 participants. It is not testing any treatment, so results may not lead to direct benefits.

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 30 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

US adults aged 18-44 years with self-reported MDD, GAD, PTSD, or Panic Disorder. Recruited via Neurobiologix and Tiny Health digital platforms and social media. Decentralized, direct-to-participant model.

Ages

18 to 44 years

Sex

Anyone

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.

Inclusion Criteria: 1. Age: Adults aged 18 to 44 years. 2. Residency: Current legal residents of the United States. 3. Clinical Phenotype: Self-report of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), or Panic Disorder. 4. Medication Stability: If currently prescribed psychotropic medications (e.g., SSRIs, SNRIs, benzodiazepines), the dosage must remain stable with no changes in molecule or quantity for at least 3 months prior to enrollment. 5. Language and Technology: Proficiency in English and access to a smartphone or computer for digital data entry. 6. Financial Commitment: Explicit agreement to the "Citizen Science" model, including payment for discounted testing kits. Kit shipping (both directions) is prepaid by the study. Exclusion Criteria: 1. Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen collection. 2. Regular use of commercial probiotics or concentrated prebiotic supplements within 4 weeks of collection. 3. Frequent use of osmotic or stimulant laxatives, or motility agents, within 4 weeks of collection. 4. Chronic use (\>3 times/week) of NSAIDs, systemic corticosteroids, or high-dose Omega-3 supplementation (\>2g/day) within 4 weeks of enrollment. 5. Use of weight-loss medications or GLP-1 receptor agonists (e.g., semaglutide, liraglutide, tirzepatide) within the 3 months prior to enrollment. 6. Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric/intestinal resection. 7. Current pregnancy or lactation. 8. Presence of cognitive impairments that preclude the ability to provide informed consent. 9. Individuals undergoing active cancer treatment.

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Conditions

The condition(s) this trial relates to.

generalized anxiety disorder major depressive disorder panic disorder post-traumatic stress disorder

As listed by the trial registrant

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

Anxiety disorder generalized Major depressive disorder (MDD) Panic disorder Stress disorders, post-traumatic

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.