Aspirin is one of the oldest drugs, widely used for pain relief, suppression of inflammation and prevention of heart disease and stroke. However, well known to many patients is a troublesome side effect of intestinal damage and ulcers.
A remarkable first-of-its-kind study from Cork reveals that bifidobacteria can prevent aspirin-induced intestinal ulcers in humans.
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).
The new study is unique in several respects. Firstly, it builds on scientific observations from APC Microbiome Ireland published earlier this year which showed that some bifidobacteria produce a protective protein which promotes healing of the intestinal epithelial lining (Molecular Microbiology January, 2019 doi: 10.1111/mmi.14155).
Secondly, the new work now provides objective endoscopic (photographic) evidence in human volunteers that aspirin-induced ulcers can be reduced by bifidobacteria. Finally, the work involved a 4-way collaboration among clinicians at the Mercy Hospital in Cork under the direction of Dr. Martin Buckley, investigators at Cork’s APC Microbiome Ireland directed by Fergus Shanahan, in collaboration with local Cork company Atlantia Food Clinical Trials and in association with Chr. Hansen.
“Although prior studies have described stomach damage from aspirin and non-steroidal anti-inflammatory drugs, this is, to the best of our knowledge, the first trial to record a detailed time-course of aspirin-induced, small-intestinal damage. Even more impressive was the subsequent reversal of the damage by the bifidobacterium that could be added as a natural supplement to the diet of patients on long-tern aspirin”
said Dr Martin Buckley.
Atlantia Food Clinical Trials is an innovative company that designs and delivers clinical studies for functional ingredients, supplements, pre- and probiotics, medical foods, infant formula and microbiome-based therapeutic sectors. A spin-out of APC Microbiome Ireland SFI Research Centre at University College Cork, Atlantia has operations in Cork, Ireland and Chicago, USA.
“Atlantia is one of the world’s leading multicentre, multinational trial facilities specialising in food and nutraceutical clinical trials. Our highly trained and experienced teams enable us to conduct and manage complex studies across all health areas for our growing global customer base. To be involved in a clinical programme with Chr. Hansen, that has such a potentially large benefit to people everywhere, is a great testament to the quality of the research Atlantia provided, coupled with the commitment of the Chr. Hansen team”
said Andrea Doolan, CEO, Atlantia Food Clinical Trials.
“This case study is an excellent example of a collaboration between an SFI Research Centre, APC Microbiome Ireland, an innovative Irish SME, Atlantia Food Clinical Trials, multinational biosciences company Chr. Hansen and the Mercy University Hospital”
said Prof Fergus Shanahan, Principal Investigator APC Microbiome Ireland.
“The four partners collaborated synergistically to deliver a high quality clinical study, which could not have been carried out by the teams individually.”
The research is published in the prestigious journal, Gastroenterology (the highest impact journal in gastrointestinal science) where it also featured on the journal cover.
Brynjulf Mortensesn, Clodagh Murphy, John O’Grady, Mary Lucey, Gafer Elsafi, Lillian Barry, Vibeke Westphal, Anja Wellejus, Oksana Lukjancenko, Aron C. Eklund, Henrik Bjorn Nielsen, Adam Baker, Anders Damholt, Johan E.T. van Hylckama Vlieg, Fergus Shanahan and Martin Buckley. Gastroenterology 2019; 157:637-646 https://www.gastrojournal.org/article/S0016-5085(19)40880-9/pdf