[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643199":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":10,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":10,"studyType":41,"phases":10,"briefSummary":42,"conditions":43,"keywords":48,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":10},{"fullName":5,"class":6},"Neurobiologix","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adults with Mental Health Conditions",null,"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).",[13],"Diagnostic Test: SNP Genotyping and Gut Metagenomics",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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\u002FGenBank) and functional annotation (KEGG Orthology, CAZy).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Priscila Arbex, Ph.D., M.S., PG Cert.","CONTACT","737-400-5726","parbex@neurobiologix.com",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100643199","serotonin-variants--gut-microbiota-in-mental-health-100643199",false,"NCT07634458","Serotonin Variants & Gut Microbiota in Mental Health","Association Between Serotonin Pathway Genetic Variants and Tryptophan-Metabolizing Gut Microbiota in Adults With Mental Health Conditions: An Observational Pilot Study","Inclusion Criteria:\n\n1. Age: Adults aged 18 to 44 years.\n2. Residency: Current legal residents of the United States.\n3. Clinical Phenotype: Self-report of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), or Panic Disorder.\n4. 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.\n5. Language and Technology: Proficiency in English and access to a smartphone or computer for digital data entry.\n6. Financial Commitment: Explicit agreement to the \"Citizen Science\" model, including payment for discounted testing kits. Kit shipping (both directions) is prepaid by the study.\n\nExclusion Criteria:\n\n1. Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen collection.\n2. Regular use of commercial probiotics or concentrated prebiotic supplements within 4 weeks of collection.\n3. Frequent use of osmotic or stimulant laxatives, or motility agents, within 4 weeks of collection.\n4. Chronic use (\\>3 times\u002Fweek) of NSAIDs, systemic corticosteroids, or high-dose Omega-3 supplementation (\\>2g\u002Fday) within 4 weeks of enrollment.\n5. Use of weight-loss medications or GLP-1 receptor agonists (e.g., semaglutide, liraglutide, tirzepatide) within the 3 months prior to enrollment.\n6. Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric\u002Fintestinal resection.\n7. Current pregnancy or lactation.\n8. Presence of cognitive impairments that preclude the ability to provide informed consent.\n9. Individuals undergoing active cancer treatment.","ALL","18 Years","44 Years",{"count":39,"type":40},30,"ESTIMATED","OBSERVATIONAL","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).\n\nThis 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\u002FCAP-accredited laboratory. Gut microbiome analysis is performed by Tiny Health using deep whole-genome shotgun metagenomics (≥20 million reads) on a NextGen Illumina Platform.\n\nThe 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.",[44,45,46,47],"Major Depressive Disorder (MDD","Anxiety Disorder, Generalized","Stress Disorders, Post-Traumatic","Panic Disorder",[49,50,51,52,53,54],"gut microbiome","serotonin","tryptophan metabolism","metagenomics","SNP genotyping","gut-brain axis","NOT_YET_RECRUITING","2026-06-08",{"date":58,"type":59},"2026-06-10","ACTUAL",{"date":61,"type":40},"2026-07-01",{"date":63,"type":40},"2027-09",{"name":5,"class":6}]