Publication

Probiotic Protects Against Small-Intestinal Damage

Bifidobacterium breve Bif195 Protects Against Small-intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers

Get in touchRead more

Publication Overview

Enteropathy and small-intestinal ulcers are common side effects of non-steroidal anti-inflammatory drugs such as acetylsalicylic acid (ASA). Safe, cytoprotective strategies are needed to reduce this risk. Specific Bifidobacteria might have cytoprotective activities, but little is known about these effects in humans. We used serial video capsule endoscopy (VCE) to assess the efficacy of a specific Bifidobacterium strain in healthy volunteers exposed to ASA. We performed a single-site, double-blind, parallel-group, proof of concept analysis of 75 heathy volunteers given ASA (300 mg) daily for 6 weeks, from July 31 through October 24, 2017. The participants were randomly assigned (1:1) to groups given oral capsules of Bifidobacterium breve (Bif195; ≥ 5*1010 colony forming units) or placebo, daily for 8 weeks. Small-intestinal damage was analyzed by serial VCE at 6 visits. The area under the curve (AUC) for intestinal damage (Lewis score) and the AUC value for ulcers were the primary and first-ranked secondary endpoint of the trial, respectively.

Publication Results

Efficacy data were obtained from 35 participants given Bif195 and 31 given placebo. The AUC for Lewis score was significantly lower in the Bif195 group (3040 ± 1340 arbitrary units) than the placebo (4351 ± 3195 arbitrary units) (P=.0376). The AUC for ulcer number was significantly lower in the Bif195 group (50.4 ± 53.1 arbitrary units) than in the placebo group (75.2 ± 85.3 arbitrary units) (P=.0258). Twelve adverse events were reported from the Bif195 group and 20 from the placebo group. None of the events were determined to be related to Bif195 intake. In a randomized double-blind trial of healthy volunteers, we found oral Bif195 to safely reduce the risk of small-intestinal enteropathy caused by ASA.

Sponsor & Volunteer Testimonials

“Extremely impressed on delivery of project... ”

“Updates were relevant and timely, I never felt that I wasnt informed properly. Extremely impressed on delivery of project during the COVID-19 pandemic. Clearly a lot of effort and work has been put in to making sure operations have been running as close to perfect as possible.”

- Nutrition Scientist at the largest producer of dairy products in Scandinavia

“very flexible and responsive, very transparent..."

"High quality work, expertise in nutritional intervention studies, very flexible and responsive, very transparent. Atlantia has a personal touch which makes working with you a lot of fun. It was assuring and great to see that the leadership are very knowledgeable and still very much involved in details of the work".

- Nutrition Manager at a global leader in collagen-based solutions

“Adaptability with trial design and inputs is great!"

"Adaptability with trial design and inputs is great! I expect them to be able to answer the questions I have and they always do."

‍

- Head of Clinical and Regulatory Affairs at revolutionary company tackling diabetes, heart disease, and obesity

“I trust Atlantia in their capabilities...”

"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".
‍

- Nutrition Research Manager at multinational functional ingredients company tackling bone health

“...expertise, way of working and customer friendliness... ”

"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)"

‍

- Nutrition Scientist at multinational functional ingredients company tackling body composition

“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

“...very professional and friendly..."

"All the staff I have met have been very professional and friendly and the trials have been interesting, educational and ultimately beneficial to my health".

-Participant member of our volunteer database for trials

“...everything was explained perfectly”

"Very friendly staff and everything was explained perfectly, also they had to take bloods and I'm the biggest baby when it comes to needles, but I didn't even realise they were finished, they were that good."

-Volunteer who took part in our food bioavailability studies

“... treated me with respect ...”

"I thought that that the staff at Atlantia always treated me with the utmost respect and my health was always at the forefront."

-Member of our participant database who took part in multiple studies





Media & Resources