Video Camera Endoscopy (VCE)

Video Camera Endoscopy (VCE) Clinical Trials

Executive Summary

Non-Steroidal Drugs (NSAIDs) are commonly used worldwide, both as prescription-only medicines and as “over-the-counter” preparations. However, low dose use of NSAIDS, is associated with gastrointestinal (GI) injury. Strategies to prevent GI complications associated with NSAID use included are generally associated with undesired side effects, whereas live bacteria formulated as probiotics may offer a safe alternative to prevent or at least decrease negative side effects of NSAIDS such as Aspirin. The present clinical trial is aiming to bring a product containing a probiotic strain able to attenuate and/or reverse Aspirin-induced small intestinal damage and GI symptoms in Aspirin users. Challenges and Objectives Anti-Inflammatory

We established a clinical challenge model aiming at investigating the ability of the probiotic strain in attenuating and/or reversing deterioration in the healthy human gastrointestinal tract

The Sponsor needed a highly experienced research partner able to assess the deterioration of small intestinal mucosa tissue however they needed a method not too invasive in order to overcome the Ethical burdens. The main objectives were: • To investigate the ability of the probiotic strain to attenuate and/or reverse low-dose, long-term Aspirin-induced deterioration of small intestinal mucosa tissue as assessed by capsule endoscopy in healthy volunteers • To investigate the ability of the probiotic strain to attenuate and reverse low-dose, long termAspirin-induced GI symptoms as assessed AUC ulcer number as well as assessed by AUC of pain syndrome score for GSRS. • To investigate co-administration of the probiotic strain to low-dose, long term Aspirin on changes in multiple biomarkers of general intestinal barrier function in blood and faecal samples. How Atlantia’s Solution Helped Consequently, we established a clinical challenge model aiming at investigating the ability of the probiotic strain in attenuating and/or reversing deterioration in the healthy human gastrointestinal tract. Thedeteriorationwas inducedby a chemical agent commonlyusedand with well-established deteriorating effects on the small intestine. For the primary endpoint, we used the method capsule endoscopy (CE) to assess the small intestinal damage. Capsule endoscopy has been reviewed in a technology status evaluation report by the American society for gastrointestinal endoscopy and it is now the gold standard for assessing occult gastrointestinal bleeding, and indications for its use are continuing to expand. Current uses include exploration and surveillance of bowel pathology such as in Crohn’s disease, polyps, small bowel malignancy and drug-induced mucosal injury. Capsule endoscopy (CE) is generally a safe and well tolerated procedure. Atlantia has a highly expert team on managing these technologies when conducting trials and was a perfect fit for the sponsor.

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