the effect of a probiotic strain on aspirin-induced gi damage

Conditions: Reduction of Small Intestinal Ulceration Risk

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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