Serotonin Variants & Gut Microbiota in Mental Health (NCT07634458) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Serotonin Variants & Gut Microbiota in Mental Health
30 participantsStarted 2026-07-01
Plain-language summary
This observational pilot study investigates whether a broad panel of genetic variants relevant to the serotonin pathway (including serotonergic system, methylation cycle, intestinal barrier integrity, and inflammatory response genes) are associated with distinct gut microbiome compositional and functional signatures in adults aged 18-44 years with self-reported mental health conditions (Major Depressive Disorder, Generalized Anxiety Disorder, PTSD, or Panic Disorder).
This is a decentralized, participant-funded (Citizen Science) study. Eligible participants provide at-home saliva (buccal swab) and stool samples. Genomic analysis is performed using the NeuroBiologix GenePro+ SNP Panel (Illumina Infinium Global Screening Array-24, \~654,000 SNPs) via Gene By Gene, a CLIA/CAP-accredited laboratory. Gut microbiome analysis is performed by Tiny Health using deep whole-genome shotgun metagenomics (≥20 million reads) on a NextGen Illumina Platform.
The study is non-interventional and hypothesis-generating, aiming to identify potential genotype-microbiome associations and estimate effect sizes to inform a future interventional trial. N=30 participants. Study Start: July 2026.
Who can participate
Age range
18 Years – 44 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: Adults aged 18 to 44 years.
. Residency: Current legal residents of the United States.
. Clinical Phenotype: Self-report of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), or Panic Disorder.
. 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.
. Language and Technology: Proficiency in English and access to a smartphone or computer for digital data entry.
. Financial Commitment: Explicit agreement to the "Citizen Science" model, including payment for discounted testing kits. Kit shipping (both directions) is prepaid by the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at connections between gut bacteria, serotonin, and conditions like depression, anxiety, PTSD, and panic disorder — would my specific diagnosis make me a relevant candidate to even discuss with the research team once they start recruiting?
2Since this trial hasn't started recruiting yet, how long might I realistically be waiting, and is there anything I should be doing for my mental health in the meantime rather than waiting for a study that may not open soon?
3This appears to be an observational or exploratory study measuring gut microbiome profiles rather than testing a new treatment — does that mean participating wouldn't change or replace my current care plan in any way?
4Given that the study is focused on serotonin-related genetic variants and gut bacteria, would my current medications — especially any antidepressants that affect serotonin — potentially affect whether I'd be eligible or whether my data would even be useful to the researchers?
5Are there other active trials or established treatments for my condition that I should be considering right now, rather than waiting for a study that is still in the pre-recruitment phase?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut Microbiome Compositional and Functional Profile
Timeframe: At study completion (approximately 8-12 weeks after enrollment)
. Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen collection.
. Regular use of commercial probiotics or concentrated prebiotic supplements within 4 weeks of collection.
. Frequent use of osmotic or stimulant laxatives, or motility agents, within 4 weeks of collection.
. Chronic use (\>3 times/week) of NSAIDs, systemic corticosteroids, or high-dose Omega-3 supplementation (\>2g/day) within 4 weeks of enrollment.
. Use of weight-loss medications or GLP-1 receptor agonists (e.g., semaglutide, liraglutide, tirzepatide) within the 3 months prior to enrollment.
. Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric/intestinal resection.
. Current pregnancy or lactation.
. Presence of cognitive impairments that preclude the ability to provide informed consent.