The Effect of a Probiotic Strain on Aspirin-induced GI Damage.

The Effect of 8 Weeks Intake of a Probiotic Strain on a 6 Week Aspirin-induced Intestinal Deterioration Challenge in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Two Armed, Parallel Group Trial.

This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.

The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks, probiotic strain/placebo is given for two additional weeks to investigate the potential effects of the probiotic strain on intestinal healing after long-time Aspirin use.

Subjects will participate in the trial for a total duration of 10 weeks including the run-in phase. Besides the screening visit, the trial will consist of 6 visits.

After having given their written informed consent, subjects will complete 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 Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in a ratio of 1:1.

Inclusion Criteria:

• Written informed consent
• Healthy and without any gastrointestinal discomfort/pain symptoms
• Age ≥ 18 - ≤ 40 years of both gender (aim of 1/3 of each gender in each arm)
• Sedentary lifestyle (weekly training load below 2 hours within endurance sports)
• Willing 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 Aspirin
• History of H. pylori disease
• Resting diastolic blood pressure ≥ 90 mmHg
• Resting systolic blood pressure ≥ 140 mmHg
• A current diagnosis of psychiatric disease
• Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
• BMI > 27
• Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (Aspirin, 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
• Lactose intolerance
• 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 2 months
• 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 PPI within last 2 months prior to screening
• Use of immunosuppressant drugs within last 4 weeks prior to screening
• For Women: Pregnancy or lactation