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

Launched by CHR HANSEN · Sep 6, 2022

Keywords

ClinConnect Summary

The study is a randomized, double-blind, 3-arm, placebo-controlled pilot study in an elderly population (60-85 years) with low-grade inflammation (hs-CRP 2-10 mg/L) comparing two doses daily intake of Bif-038 at 1 and 10 billion CFU to placebo for 12 weeks. The subjects will receive either one of the two test products or the placebo product daily for a period of 12 weeks.

During the entire study period, five visits are scheduled. The subjects will participate in two screening visits; a baseline visit, a visit after 6 weeks of intervention and an end-of-study visit after 12 weeks of interve...

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Eligibility criteria

• 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: ≥ 60 years and ≤ 85 years
• • hs-CRP: 2.0-10.0 mg/L
• • BMI: 18.5-32 kg/m2
• • Temperature between ≥35.5 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, 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 oral non-steroidal anti-inflammatory medication use (1 week) (topical NSAIDS allowed). 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. Current smoking, chewable tobacco and/or vaping. Low dose (\<50mg/week) nicotine products allowed.
• • 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.