Side Effects of Acetylsalicylic Acid Use Clinical Trial
Official title:
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.
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