Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
NCT ID: NCT05529693
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2022-09-29
2023-12-01
Brief Summary
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Detailed Description
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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 intervention. Visit 1 and 2 are screening- and recruitment visits with at least two weeks apart. Only participants with a hs-CRP within 2.0-10.0 mg/L will be invited for the second screening visit. Participants with repeated hs-CRP levels within 2.0-10.0 mg/L will be invited for baseline visit 3, to be included and randomized in the study.
At the screening visits the eligibility will be checked after the participants have given their written informed consent.
Blood samples and stool samples will be collected during the study and subjects will be asked to complete questionnaires and a dietary diary.
No sample size calculations were performed due to the exploratory nature of a pilot study design. Planned number to include is 20 subjects per study arm, thus 60 subjects in total.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Bif-038 arm, high dose
Active trial product with minimum 10 billion CFU daily dose
Experimental: Bif-038 arm, high dose
Active trial product with minimum 10 billion CFU daily dose
Bif-038 arm, low dose
Active trial product with minimum 1 billion CFU daily dose
Experimental: Bif-038 arm, low dose
Active trial product with minimum 1 billion CFU daily dose
Placebo arm
Similar trial product, but without Bif-038 probiotic bacteria
Placebo Comparator: Placebo arm
Similar product to trial product but without Bif-038
Interventions
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Experimental: Bif-038 arm, high dose
Active trial product with minimum 10 billion CFU daily dose
Experimental: Bif-038 arm, low dose
Active trial product with minimum 1 billion CFU daily dose
Placebo Comparator: Placebo arm
Similar product to trial product but without Bif-038
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
60 Years
85 Years
ALL
Yes
Sponsors
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Chr Hansen
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Dinan, Professor
Role: PRINCIPAL_INVESTIGATOR
Atlantia Clinical Trials
Locations
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Atlantia Food Clinical Trials
Cork, , Ireland
Countries
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Other Identifiers
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HND-IM-047
Identifier Type: -
Identifier Source: org_study_id