VCE Trial Published in Gastroenterology
Gastroenterology publish a probiotic clinical study using Video Capsule Endoscopy (VCE) technology
The VCE publication
A recent paper exploring the effects of Bifidobacterium breve Bif195 Protects Against Small-intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers was published in Gastroenterology. This journal has been listed as one of the most informative journals in relation to Gastrointestinal disease. Gastroenterology is popular due to its up to date information in both clinical and basic gastroenterology. Original research is organized by clinical and basic-translational content, as well as alimentary tract, liver, pancreas, and biliary content. Gastroenterology is ranked 1st of 80 journals in the Gastroenterology and Hepatology category on the 2017 Journal Citation Reports®, published by Clarivate Analytics, and has an Impact Factor of 20.773.
The article was based on a study designed and conducted by Atlantia Clinical Trials, in conjunction with its academic partner APC Microbiome Ireland.
The VCE clinical trial
The clinical trial aimed to bring a product containing a probiotic strain able to attenuate and/or reverse NSAIDs-induced small intestinal damage and GI symptoms in NSAIDs users. One common side effect of anti-inflammatory drugs like Acetylsalicylic Acid (ASA) is small intestinal ulcers. The purpose of this trial was to examine the efficacy of a specific Bifidobacterium strain in healthy volunteers whom were exposed to Acetylsalicylic Acid using a video capsule endoscopy. This trial was a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel group trial in healthy, adult volunteers. The participants were randomly assigned either the product or the placebo product so that a result could be concluded at the end of the 8 weeks. The trial included a run-in period of two weeks duration followed by a six-week intervention period where the probiotic/placebo and NSAIDs 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 NSAIDs use. Subjects participated in the trial for a total duration of 10-weeks including the run-in phase. At the end of the trial, results had shown that the product was successful in reducing the risk of enteropathy in humans taking Acetylsalicylic Acid (ASA).
Atlantia were delighted to take on the task of completing this trial efficiently, on budget on time and appreciated the acknowledgement by the sponsors of the trial:
‘We would like to acknowledge all of the involved staff at the CRO Atlantia Clinical Trials, Cork Ireland for an efficient and professional conduct of the trial on behalf of the sponsor’.
Although prior studies have described gastric damage from NSAIDs, this is, to the best of our knowledge, the first trial to record the detailed time-resolved kinetics of ASA-induced, and reversal of, small-intestinal damage- the research team concluded in the paper.
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