Clinical trial NCT05529693: Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
Official title: Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population - a Randomized, Double-blind, Placebo-controlled, Parallel Group Pilot Study With 12 Weeks Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population

Detailed description: 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 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.

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.

Primary outcomes:
measure: hs-CRP
timeFrame: 12 weeks
Secondary outcomes:
measure: TNF-alfa
timeFrame: 12 weeks
Other outcomes:
measure: Change in hsCRP
timeFrame: 6 and 12 weeks
measure: Change in TNF-alfa
timeFrame: 6 and 12 weeks
measure: Change in feces borne biomarker calprotectin
timeFrame: 12 weeks
measure: Change in Health-related Quality of Life
timeFrame: 6 and 12 weeks
measure: Change in mental health
timeFrame: 6 and 12 weeks
measure: Change in well-being
timeFrame: 6 and 12 weeks
measure: Change in microbiome
timeFrame: 12 weeks
measure: Change in Zonulin
timeFrame: 6 and 12 weeks
measure: Change in lipopolysaccharide-binding protein
timeFrame: 6 and 12 weeks
measure: Change in intestinal fatty-acid binding protein
timeFrame: 6 and 12 weeks
measure: Change in CD4/CD8 ratio
timeFrame: 6 and 12 weeks
measure: Change in Interleukin-6
timeFrame: 6 and 12 weeks
measure: Change in Interleukin-10
timeFrame: 6 and 12 weeks
measure: Change in body weight
timeFrame: 6 and 12 weeks
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
affiliation: Atlantia Clinical Trials
name: Timothy Dinan, Professor
role: PRINCIPAL_INVESTIGATOR
References: