Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years)

Last updated: February 7, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05603455
2022-LHZHZ
  • Ages 45-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will include middle-aged and elderly people aged 45-65 years to carry out the translational study of Bifidobacterium adolescentis, and design a double-blind, randomized controlled clinical trial according to strict inclusion/exclusion criteria, using aging-related functional indicators, intestinal flora, DNA methylation and other advanced aging characteristic examination methods to fully and accurately assess the effects and safety of Bifidobacterium adolescentis on aging, which has the advantages of strong safety, high practice and high credibility compared with previous clinical trial protocols, laying an important foundation for improving probiotic anti-aging and exploring the development of aging intervention programs suitable for the Chinese population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 45-65 years of age.
  2. Attending or consulting at the specialized outpatient clinics for aging diseases at 2nd Affiliated Hospital, School of Medicine, Zhejiang University and Sir Run RunHospital, School of Medicine, Zhejiang University
  3. Voluntarily participate in this study and sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Known history of tumor.
  2. women who are breastfeeding.
  3. Those who wish to continue having children.
  4. those who are unable to cooperate with investigations and testing
  5. abuse of drugs, alcohol or other substances.
  6. history of cardiac disease: atherosclerotic disease, heart failure, unstable angina,stable angina, etc. and chronic hypoxic diseases: emphysema, pulmonary heart disease,etc.
  7. history of chronic gastrointestinal diseases (pancreatitis, IBS) and intestinalsurgery.
  8. endocrine disease with hyperthyroidism or cortisolism.
  9. abnormal liver function, with ALT（Alanine transaminase）/AST（Aspartateaminotransferase） exceeding 2 times the upper limit of normal.
  10. abnormal renal function with blood creatinine ≥ 133 μmol/L.
  11. Type I diabetes or insulin-dependent type II diabetes.
  12. poorly controlled chronic disease (hypertension, hyperlipidemia, type II diabetes,etc.) that is clinically unstable.
  13. Vulnerable groups, including critically ill, mentally ill, cognitively impaired,minors, pregnant women, illiterate, etc.

Study Design

Total Participants: 100
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Sir RUN RUN Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 317000
    China

    Site Not Available

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