Serotonin Variants & Gut Microbiota in Mental Health

NCT07634458 | Not Yet Recruiting

• 1 other identifier: 16153
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Panic Disorder; Anxiety Disorder, Generalized; Stress Disorders, Post-Traumatic; Major Depressive Disorder (MDD

Keywords

gut microbiome; serotonin; tryptophan metabolism; metagenomics; SNP genotyping; gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Gut Microbiome Compositional and Functional Profile

  Shotgun metagenomic sequencing of stool samples to assess gut microbial taxonomic composition (alpha and beta diversity) and functional potential, specifically tryptophan metabolism pathways (KEGG Orthology), and their association with host genetic variants in the serotonin pathway.

  At study completion (approximately 8-12 weeks after enrollment)

Study Arms (1)

Adults with Mental Health Conditions

US adults aged 18-44 years with self-reported MDD, GAD, PTSD, or Panic Disorder who are on stable psychotropic medication (or unmedicated). Participants provide at-home saliva and stool samples for genomic SNP analysis (NeuroBiologix GenePro+ SNP Panel) and gut microbiome shotgun metagenomics sequencing (Tiny Health platform).

Diagnostic Test: SNP Genotyping and Gut Metagenomics

Interventions

SNP Genotyping and Gut Metagenomics DIAGNOSTIC_TEST

Genomic analysis using NeuroBiologix GenePro+ SNP Panel: Illumina Infinium Global Screening Array-24 v3.0 (\~654,000 SNPs), genotyped at Gene By Gene (CLIA No. 45D1102202, CAP-accredited). Data processed via OmicsEdge bioinformatics platform analyzing serotonergic, methylation, intestinal barrier, and inflammatory pathway variants. Gut microbiome analysis using Tiny Health deep whole-genome shotgun metagenomics (NextGen Illumina Platform, ≥20 million reads), with taxonomic profiling (GTDB/GenBank) and functional annotation (KEGG Orthology, CAZy).

Adults with Mental Health Conditions

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Individuals undergoing active cancer treatment.

Sponsors & Collaborators

• Neurobiologix: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Stress Disorders, Post-Traumatic; Panic Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Priscila Arbex, Ph.D., M.S., PG Cert.

CONTACT

737-400-5726; parbex@neurobiologix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share