Video Camera Endoscopy (VCE) Clinical Trials
About the Study This trial was a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. It investigated the effect of daily intake of the probiotic strain or placebo when co-administered with daily intake of 300mg of Aspirin.
The trial was conducted in accordance with the ethical principles set forth in the current version of the Declaration of Helsinki (seventh revision; October 2013), the International Conference on Harmonization E6 Good Clinical Practice (ICH-GCP, 10 June 1996) and all applicable local regulatory requirements. The trial included a run-in period of two weeks duration followed by a six-week intervention period where the probiotic/placebo and Aspirin were co-administered. After the 6-weeks, the probiotic/placebo was given for two additional weeks to investigate the potential effects of the probiotic on intestinal healing after long-time Aspirin use. Subjects participated in the trial for a total duration of 10-weeks including the run-in phase. The trial consisted of 6 visits following screening. The primary efficacy variable was to investigate the effect of 8-weeks oral supplement of the probiotic strain versus placebo on small intestinal mucosa damage when co-administered with an Aspirin challenge for 6-weeks measured as the area-under-the-curve (AUC) for Lewis Score obtained by capsule endoscopy. The sample size of 30 completing participants in each arm was estimated based on a power calculation performed on intervention on percent difference of AUC between two normalized curves (active vs. placebo) as an approximation. To account for a potential drop-out rate of approximately 15%, a total of 35 subjects were randomized in each group. A decrease of 30% in the AUC following treatment of the probiotic compared to placebo was considered to be clinically relevant and detected as significant.
Throughout the entire trial, subjects were instructed to maintain their habitual life style with regard to diet, physical activity level and sleep habits. Intake of probiotic products aswell as food and food supplements containing probiotics were not allowed from the screening visit and until the end of the intervention period. Subjects were not withdrawn from the trial due to single violations, but violations were recorded as protocol deviations. Small intestine mucosa deterioration was evaluated using capsule endoscopy as well as indirect biomarkers in feaces and blood samples At these visits, subjects also filled out the GSRS questionnaire which assessed GI symptoms and pain. Each subject underwent video capsule endoscopy after 1-week and 4-weeks of taking aspirin and omeprazole, along with either investigational product or placebo therapy. The primary endpoint was to evaluate small bowel damage in healthy subjects before and after taking low-dose aspirin for 4-week16. Capsule endoscopy was deemed to be a relevant and acceptable method to evaluate both mild and severe intestinal damage caused by low dosage of Aspirin measured as area-under-the-curve for damage observed by capsule endoscopy over the 8 week trial intervention period.
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