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Serotonin Variants & Gut Microbiota in Mental Health: Pilot Study

4. juni 2026 opdateret af: Neurobiologix

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background: The gut-brain-microbiota axis (GBA) represents a complex, bidirectional communication system. Microbial tryptophan metabolism is a key mechanism within this axis - approximately 95% of the body's serotonin is synthesized peripherally in the gut. Host genetic variants can influence both serotonin biology and gut microbiome composition.

Objective: To explore correlations between multi-system genetic variants (TPH2, SLC6A4, MTHFR, FUT2, MUC1, IL-6, and others) and gut microbiome compositional and functional profiles (particularly tryptophan metabolism pathways) in adults with self-reported mental health conditions.

Design: Decentralized observational pilot study. Participants complete digital questionnaires and provide at-home biospecimen collections (saliva and stool) using prepaid medical-grade kits.

Genomic Methodology: Saliva samples undergo DNA extraction and array-based genotyping (Illumina GSA-24 v3.0) at Gene By Gene (CLIA No. 45D1102202, CAP-accredited). Data processed via OmicsEdge bioinformatics platform.

Metagenomic Methodology: Stool samples analyzed by Tiny Health using whole-genome shotgun metagenomics. Human reads are depleted against GRCh38. Taxonomic profiling via GTDB/GenBank database (111,000+ genomes). Functional annotation via KEGG Orthology and CAZy.

Statistical Analysis: Descriptive statistics; alpha diversity (Shannon index); beta diversity (Bray-Curtis dissimilarity); PERMANOVA; exploratory non-parametric comparisons between genotype-defined groups. Effect sizes calculated for future study design.

IRB: Approved by Sterling Institutional Review Board (Atlanta, GA), IRB ID 16153.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  1. Age: Adults aged 18 to 44 years.
  2. Residency: Current legal residents of the United States.
  3. Clinical Phenotype: Self-report of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), or Panic Disorder.
  4. 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.
  5. Language and Technology: Proficiency in English and access to a smartphone or computer for digital data entry.
  6. Financial Commitment: Explicit agreement to the "Citizen Science" model, including payment for discounted testing kits. Kit shipping (both directions) is prepaid by the study.

Exclusion Criteria:

  1. Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen collection.
  2. Regular use of commercial probiotics or concentrated prebiotic supplements within 4 weeks of collection.
  3. Frequent use of osmotic or stimulant laxatives, or motility agents, within 4 weeks of collection.
  4. Chronic use (>3 times/week) of NSAIDs, systemic corticosteroids, or high-dose Omega-3 supplementation (>2g/day) within 4 weeks of enrollment.
  5. Use of weight-loss medications or GLP-1 receptor agonists (e.g., semaglutide, liraglutide, tirzepatide) within the 3 months prior to enrollment.
  6. Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric/intestinal resection.
  7. Current pregnancy or lactation.
  8. Presence of cognitive impairments that preclude the ability to provide informed consent.
  9. Individuals undergoing active cancer treatment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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).
Diagnostisk 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gut Microbiome Compositional and Functional Profile
Tidsramme: At study completion (approximately 8-12 weeks after enrollment)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Neurobiologix

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16153

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared due to the sensitive nature of genomic and mental health data. De-identified aggregate data and findings will be reported in peer-reviewed publications.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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