Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:57 AM
Study NCT ID:
NCT07407894
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Gut Microbiota Composition', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in gut microbiome composition and diversity assessed using metagenomic sequencing of fecal samples compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Gut Microbiota Function', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in gut microbiome function assessed using metagenomic sequencing of fecal samples compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Fecal Metabolites', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in fecal and plasma metabolites, including short-chain fatty acids (SCFAs), bile acids, and trimethylamine N-oxide (TMAO) compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Gut Permeability Markers', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in gut permeability markers assessed using validated enzyme-linked immunosorbent assay (ELISA) techniques compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Inflammatory Markers', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in inflammatory markers assessed using validated enzyme-linked immunosorbent assay (ELISA) techniques compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}], 'primaryOutcomes': [{'measure': 'Change in Biological Aging Biomarkers', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in gene expression of biomarkers associated with biological aging, assessed by quantitative polymerase chain reaction (qPCR), compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.'}], 'secondaryOutcomes': [{'measure': 'Change in Phenotypic Age', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in Phenotypic Age calculated as a single value from blood-based biomarkers (albumin, creatinine, glucose, C-reactive protein, lymphocyte count, mean cell volume, red cell distribution width, alkaline phosphatase, and white blood cell count) and chronological age compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Bifidobacterium adolescentis iVS-1 Abundance', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in fecal Bifidobacterium adolescentis iVS-1 abundance, assessed by quantitative polymerase chain reaction (qPCR), compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Metabolic Health', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in metabolic health biomarkers assessed by Comprehensive Metabolic Panel (CMP) compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Lipid Profiles', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in lipid profiles assed by a lipid panel compared between placebo and study product groups over the study duration, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Cognitive Function', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in global and executive cognitive function assessed using validated cognitive assessments compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Sleep Quality', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline to Day 150', 'description': 'Changes in quality-of-life scores assessed using the Short Form-36 Health Survey (SF-36) compared across timepoints and between placebo and study product groups, including stratified analyses based on Bifidobacterium abundance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bifidobacterium adolescentis', 'iVS-1', 'Aging', 'Geroscience', 'Gut Microbiome', 'Probiotic', 'Healthspan'], 'conditions': ['Healthy Aging', 'Anti Aging']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation on biological aging markers, metabolic health, and functional health outcomes in midlife adults. The study explores whether modulation of aging-related biological pathways through the gut microbiome may influence health-related outcomes.', 'detailedDescription': 'Aging is associated with progressive physiological changes involving inflammation, cellular senescence, mitochondrial function, and alterations in the gut microbiome. Interventions targeting these biological processes may influence age-related health outcomes. The gut microbiome plays a central and modifiable role, influencing metabolic health, inflammation, neurocognitive outcomes, and systemic aging processes.\n\nReductions in Bifidobacterium adolescentis have been observed with aging and have been associated with metabolic and inflammatory changes. Preliminary studies suggest that supplementation with this species may affect biological pathways relevant to aging.\n\nThis study is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation in adults aged 40-75 years. Participants will be randomized to receive iVS-1 (≥8 billion CFU per capsule) or placebo once daily for 150 days. Blood- and stool-based assessments and questionnaires about cognition, sleep quality, and quality of life will be collected at baseline, mid-intervention, and end of study.\n\nChanges in these measures will be used to assess the relationship between Bifidobacterium adolescentis iVS-1 supplementation and biological aging markers, metabolic health, and functional health outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40-75 years.\n* BMI: 20-34.9 kg/m².\n* Able and willing to sign informed consent and participate for the study duration.\n\nExclusion Criteria:\n\n* Chronic disease history (liver, kidney, heart).\n* Current pregnancy and/or lactating.\n* Colonoscopy and/or its preparation within 4 weeks of screening.\n* Those who intend to have children during study period.\n* Current probiotic, prebiotics and/or metabolic-altering supplement use.\n* Those who are unable to cooperate with investigators and testing.\n* Known history of cancer and/or ongoing cancer treatments.\n* Abuse of drugs, alcohol, tobacco, nicotine and other substances.\n* History of cardiac diseases: atherosclerosis, heart failure, unstable angina, stable angina, etc., and chronic hypoxic disease: emphysema, pulmonary heart disease and others related.\n* History of chronic and major GI disease (pancreatitis, IBS, and IBD) and intestinal surgeries.\n* Type 1 or 2 diabetes mellitus.\n* Poorly controlled chronic diseases (hypertension, hyperlipidemia) that are clinically unstable.\n* Vulnerable groups, including clinically ill, mentally ill, cognitively impaired, minors, and illiterate etc.\n* Significant weight loss (\\>20%) in prior one month.\n* Conditions affecting safety or outcome integrity.'}, 'identificationModule': {'nctId': 'NCT07407894', 'acronym': 'VITAL', 'briefTitle': 'iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synbiotic Health'}, 'officialTitle': 'VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)', 'orgStudyIdInfo': {'id': 'MB-VITAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bifidobacterium adolescentis iVS-1', 'description': 'Probiotic Capsule', 'interventionNames': ['Dietary Supplement: Bifidobacterium adolescentis iVS-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Bifidobacterium adolescentis iVS-1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day', 'armGroupLabels': ['Bifidobacterium adolescentis iVS-1']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsule delivered orally once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34638', 'city': 'New Port Richey', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shalini Jain, PhD', 'role': 'CONTACT', 'email': 'jains@musbresearch.com', 'phone': '813-419-0781'}, {'name': 'Shalini Jain, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MusB Research LLC', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}], 'centralContacts': [{'name': 'Shalini Jain, PhD', 'role': 'CONTACT', 'email': 'jains@musbresearch.com', 'phone': '813-419-0781'}, {'name': 'Indushekar Manjunatha', 'role': 'CONTACT', 'email': 'imanjunatha@musbresearch.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synbiotic Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MusB Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}