NCT07634458Not yet recruiting

Serotonin Variants & Gut Microbiota in Mental Health

Association Between Serotonin Pathway Genetic Variants and Tryptophan-Metabolizing Gut Microbiota in Adults With Mental Health Conditions: An Observational Pilot Study

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 30 (estimated)
First submitted: 4 Jun 2026
Start date: 1 Jul 2026
Primary completion date: Jul 2027
Lead sponsor: Neurobiologix
Diseases: Depression
NCT number: NCT07634458

What you commit to

Study type: Observational
Planned participants: 30
From 1 Jul 2026 to the primary completion date, Jul 2027
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen 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.

Other illness

Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric/intestinal resection.
Individuals undergoing active cancer treatment.

Other

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.
Current pregnancy or lactation.
Presence of cognitive impairments that preclude the ability to provide informed consent.

Who the study is looking for

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.

Age in the registry: 18 years to 44 years · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.