Serotonin Variants & Gut Microbiota in Mental Health

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-44
SponsorNeurobiologix

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SNP Genotyping and Gut Metagenomics

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators