RecruitingNot Applicable

iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults

United States80 participantsStarted 2026-02-01

Plain-language summary

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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 40-75 years. * BMI: 20-34.9 kg/m². * Able and willing to sign informed consent and participate for the study duration. Exclusion Criteria: * Chronic disease history (liver, kidney, heart). * Current pregnancy and/or lactating. * Colonoscopy and/or its preparation within 4 weeks of screening. * Those who intend to have children during study period. * Current probiotic, prebiotics and/or metabolic-altering supplement use. * Those who are unable to cooperate with investigators and testing. * Known history of cancer and/or ongoing cancer treatments. * Abuse of drugs, alcohol, tobacco, nicotine and other substances. * History of cardiac diseases: atherosclerosis, heart failure, unstable angina, stable angina, etc., and chronic hypoxic disease: emphysema, pulmonary heart disease and others related. * History of chronic and major GI disease (pancreatitis, IBS, and IBD) and intestinal surgeries. * Type 1 or 2 diabetes mellitus. * Poorly controlled chronic diseases (hypertension, hyperlipidemia) that are clinically unstable. * Vulnerable groups, including clinically ill, mentally ill, cognitively impaired, minors, and illiterate etc. * Significant weight loss (\>20%) in prior one month. * Conditions affecting safety or outcome integrity.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Biological Aging Biomarkers

Timeframe: Baseline to Day 150

Trial details

NCT IDNCT07407894

SponsorSynbiotic Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Shalini Jain, PhD

813-419-0781 jains@musbresearch.com

View on ClinicalTrials.gov More Healthy Aging trials