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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- hs-CRP
研究概览
简要总结
To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Cold or flu-like (URTI) symptoms, with a Jackson Cold Scale score of >2; not otherwise explained by seasonal allergies
- •Chronic disease such as, cardiovascular diseases, gastrointestinal disorders, and rheumatoid arthritis, which in the Investigators judgment, precludes involvement in the study
- •Oral antibiotics within 4 weeks prior to the screening visit
- •Use of immunosuppressant drugs, systemic steroids or systemic antimicrobial medication (including suppositories) within the 4 weeks prior to the screening visit
- •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.
- •Uncontrolled, unstable hypertension at the discretion of the investigator.
- •Current smoking, chewable tobacco and/or vaping. Low dose (<50mg/week) nicotine products allowed.
- •Planned change in current diet or exercise habits
- •Habitual intake of probiotic supplements within 2 months before screening visit
- •Have had gastrointestinal surgery (e.g. colectomy, cholecystectomy, gastric bypass); Appendectomy allowed. Laparoscopic surgeries (removal of polyps, cysts) are allowed.
- •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;
- •Any change in medication or supplement intake in the 30 days prior to baseline
- •Any major dietary changes in the 30 days prior to baseline
- •Has a history of drug and/or alcohol abuse at the time of enrolment;
- •Has received treatment involving experimental drugs in 2 months prior to screening
- •Any immunosuppressant or chemotherapy medications, including marcaptopurine, azothioprine, or methotrexate;
- •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.
- •Have a current malignant disease or any current concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study;
- •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.
结局指标
主要结局
hs-CRP
时间窗: 12 weeks
The effect of daily intake of Bif-038 10 billion CFU versus placebo on hs-CRP
次要结局
- TNF-alfa(12 weeks)