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Case Study

Video Camera Endoscopy (VCE) Clinical Trial

How to asset the ability of the probiotic strain to attenuate NSAIDs effect in deterioration of small intestinal mucosa tissue

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Video Camera Endoscopy (VCE) Clinical Trial

Case Study Overview

Non-Steroidal Anti-Inflammatory 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

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 term Aspirin-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.

Case Study Highlights

Study product

Probiotic strain

Study population
75

participants

Primary endpoint

Small intestinal damage and GI symptoms

Study duration
10

weeks

Video Camera Endoscopy (VCE) Clinical Trial
Case Study

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"I was satisfied of the service provided and I trust Atlantia in their capabilities to conduct successfully clinical trials. We have good previous experience together and I know Atlantia is always improving".

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"We expected (and got) solution-orientated answers in a suitable time frame, we appreciated the overall service of Atlantia (including the expertise, way of working and customer friendliness)"

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“This disease would of taken another few years to diagnose...”

"Really great people to deal with!!! I have done a few trials and have found them exceptional at what they do. I completed a pill camera trial about 2 years ago. From doing so it was found I had Crohn's disease. This disease would of taken another few years to diagnose had I not done this trial."

- Volunteer who help us and took part in our Video Camera Endoscopy trial
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