Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population

This is an interventional prevention trial for Inflammation Read More

Inclusion Criteria:

• Willing to participate in the study and comply with its procedures
• Able to give written informed consent
• Healthy adults as determined by the investigator
• Age: ≥ 65 years and ≤ 85 years
• hs-CRP: 3.0-10.0 mg/L
• BMI: 18.5-32 kg/m2
• Temperature between ≥36.5 and ≤37.3oC
• A stable body weight (≤5 % change) over the 3 months prior to screening.

Exclusion Criteria:

1. Cold or flu-like (URTI) symptoms, with a Jackson Cold Scale score of >2; not otherwise explained by seasonal allergies
2. Chronic disease such as, type-2 diabetes, cardiovascular diseases, gastrointestinal disorders, and rheumatoid arthritis, which in the Investigators judgment, precludes involvement in the study
3. Oral antibiotics within 4 weeks prior to the screening visit
4. Use of immunosuppressant drugs, systemic steroids or systemic antimicrobial medication (including suppositories) within the 4 weeks prior to the screening visit
5. Regular non-steroidal anti-inflammatory medication use (1-2 weeks). Low-dose prophylactic aspirin use is acceptable if stable for 9 months prior to screening.
6. Uncontrolled, unstable hypertension at the discretion of the investigator.
7. Smoking and/or chewable tobacco and all nicotine products including vaping.
8. Planned change in current diet or exercise habits
9. Habitual intake of probiotic supplements within 2 months before screening visit
10. Have had gastrointestinal surgery (e.g. colectomy, cholecystectomy, gastric bypass); Appendectomy allowed. Laparoscopic surgeries (removal of polyps, cysts) are allowed.
11. Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results;
12. Any change in medication or supplement intake in the 30 days prior to baseline
13. Any major dietary changes in the 30 days prior to baseline
14. Has a history of drug and/or alcohol abuse at the time of enrolment;
15. Has received treatment involving experimental drugs in 2 months prior to screening
16. Any immunosuppressant or chemotherapy medications, including marcaptopurine, azothioprine, or methotrexate;
17. Use of herbal remedies and supplements with potential anti-inflammatory properties for the duration of the study, which in the Investigators judgement may have an impact on the objectives of the study.
18. Have a current malignant disease or any current concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study;
19. Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.