Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT05529693
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT05529693
Study Brief:
Protocol Section:
NCT05529693