Recruiting

Bifidobacterium Adolescentis

Sponsor:

Synbiotic Health

Code:

NCT07407894

Conditions

Healthy Aging

Anti Aging

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Bifidobacterium adolescentis iVS-1

Placebo

Study Details

Brief 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.

Conditions

Healthy Aging

Anti Aging

Study ID

NCT07407894

Start date

Feb 1, 2026

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Bifidobacterium adolescentis iVS-1

Probiotic Capsule

placebo comparator: Placebo

Placebo capsule

Interventions

Bifidobacterium adolescentis iVS-1

B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day

Placebo

Placebo capsule delivered orally once daily

Primary outcome measure

  • Change in Biological Aging Biomarkers [ Time Frame: Baseline to Day 150 ]

Central Contacts and Locations

Central contacts

Shalini Jain, PhD

813-419-0781jains@musbresearch.com

Indushekar Manjunatha

imanjunatha@musbresearch.com

Locations

MusB Research LLC

Recruiting

New Port Richey, Florida, United States, 34638

Contacts

Shalini Jain, PhD

813-419-0781jains@musbresearch.com

Principal Investigator:

Shalini Jain, PhD

More Information

Sponsor

Synbiotic Health

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Bifidobacterium adolescentis
  • iVS-1
  • Aging
  • Geroscience
  • Gut Microbiome
  • Probiotic
  • Healthspan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Synbiotic Health on 2026-04-22.