The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- primary endpoint - Lewis score high dose Bif195 vs Placebo
研究概览
简要总结
The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.
详细描述
This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA).
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits.
After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 300mg ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195) or placebo product in a ratio of 1:1:1.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy and without any gastrointestinal discomfort/pain symptoms
- •Age 40-60 years of both genders (aim of minimum 1/3 of each gender in each arm)
- •Willing and able to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
排除标准
- •Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy)
- •History of peptic ulcer disease
- •Any known bleeding disorder
- •Allergy to ASA
- •Resting diastolic blood pressure ≥ 95 mmHg
- •Resting systolic blood pressure ≥ 150 mmHg
- •A current diagnosis of psychiatric disease
- •Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
- •Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (ASA, Ibuprofen, Diclofenac, Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin)
- •Usage of medications, except contraceptives, in the last 2 weeks prior to screening
- •Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome
- •Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject
- •Participation in other clinical trials in the past 2 months prior to screening
- •Regular use of probiotics in the last month
- •Smoking and/or frequent use of other nicotine products
- •Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial
- •Use of laxatives, anti-diarrheals, anti-cholinergics and proton pump inhibitors within last 2 months prior to screening
- •Use of immunosuppressant drugs within last 4 weeks prior to screening
- •For Women: Pregnancy or lactation
研究组 & 干预措施
Placebo
Placebo arm. Similar trial product, but without Bif195 bacteria
干预措施: Placebo (Dietary Supplement)
Low-dose Bif195
Active trial product with minimum 15 billion CFU daily dose
干预措施: Bif195 (Dietary Supplement)
High-dose Bif195
Active trial product with minimum 50 billion CFU daily dose
干预措施: Bif195 (Dietary Supplement)
结局指标
主要结局
primary endpoint - Lewis score high dose Bif195 vs Placebo
时间窗: 6 weeks
The effect of high-dose Bif195 versus placebo on small intestinal mucosal damage during a 6-week ASA challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
次要结局
未报告次要终点