MedTrace Logo

Serotonin Variants & Gut Microbiota in Mental Health

NCT07634458 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-06-10

No results posted yet for this study

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

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

Interventions

DIAGNOSTIC_TEST

SNP Genotyping and Gut Metagenomics

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).

Sponsors & Collaborators

  • Neurobiologix

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-31
Completion
2027-09-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634458 on ClinicalTrials.gov