Serotonin Variants & Gut Microbiota in Mental Health

Sponsor
Neurobiologix
Study ID
NCT07634458
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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).

Primary Outcome Measure

Gut Microbiome Compositional and Functional Profile [ Time Frame: At study completion (approximately 8-12 weeks after enrollment) ]

Central Contacts

Related Studies