iVS-1 probiotic to target biological aging in midlife adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll adults 40–75 years old to receive either iVS-1 (Bifidobacterium adolescentis, ≥8 billion CFU per capsule) or placebo once daily for 150 days. Blood and stool samples plus questionnaires on cognition, sleep, and quality of life will be collected at baseline, mid-intervention, and end of study to measure biological aging markers, metabolic health, inflammation, and gut microbiome changes. The study tests whether modulating the gut microbiome with iVS-1 can alter aging-related pathways such as inflammation, cellular senescence, and mitochondrial function. Participants with major chronic diseases, diabetes, recent colonoscopy, current probiotic use, pregnancy, or a history of significant GI or cardiac disease are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• MusB Research LLC
  New Port Richey, Florida, United States Recruiting

Study contacts

• Study coordinator: Shalini Jain, PhD
• Email: jains@musbresearch.com
• Phone: 813-419-0781

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.