Human Health Innovation

Anders Damholt

Probiotics are live microorganisms, that possess health benefits. These can be natural occurring bacteria, being part of the human microbiome. The human microbiome is present almost everywhere on the human body and is an integrated part of well-being of the human. A specific bacterium from the microbiome, selected for specific beneficial profile, purified, and industrialized, can have significant and important effects on vital functions such as the immune system, digestive health and boost your metabolism.

Two of the most widely recognized probiotics for supporting digestive and immune health are bifidobacterial and lactobacilli, which both reside in the intestine.

We have identified Bifidobacterium breve Bif195and shown that oral administration of this probiotic can reduce the risk of aspirin-induced ulcerationand damages to the small intestines. Low-dose aspirin is generally used for primary and secondary prevention of cardiovascular disease, by reducing serum prostaglandin and thromboxane.

In USA alone, it is estimated that 40% of the adult population at 50 years and older, is using aspirin for this purpose. However, about 50 % of these, will experience damage to the gastrointestinal system and ulcerations in both duodenum and ventricle are frequently observed.

In a double-blinded, randomized, placebo controlled clinical study, we included 66 healthy adult human subjects of both genders. All subjects received 300 mg aspirin every day for 6 weeks. The subjects were randomly divided into two groups, one receiving 50 billion cfu/day of Bif195 and the other receiving placebo for 8 weeks. On top of active and placebo treatment subjectsreceivedaspirin for 6 weeks and the following 2 weeks, without aspirin.The damage to the small intestine wasassessed with the use of video capsule endoscopy, which was performed at six visits doing the eight weeks intervention. The aspirin-induced damage was scored by qualified gastroenterologist and evaluated as change in Lewis score (ulcer numbers, villus oedema and stenosis). The result was then given as average AUC (area under the curve).

The results from the study showed, that Bif195 significantly reduced the 6 weeks aspirin-induced damage to the small intestine as assessed by Lewis score and number of ulcers.

Healthy subjects took aspirin for 6 weeks period aspirin 6 weeks. Starting the same time subjects took either Bif195 or placebo for 8 weeks.

Lewis Score and Ulcer Number were significantly reduced by intake of Bif195: (A and B: Lewis score; 30 precent lower, p=0.04. C and D: Ulcer number 33 percent lower, *p<0.05. AUC (area under the curve).

Aspirin induced damaged to the small intestine; pictures taken with the capsule endoscopy camera in subjects taken aspirin with either Bif195 or placebo.

Healthy subjects took aspirin 6 weeks. Starting the same time subjects took either Bif195 or placebo for 8 weeks.

Aspirin induced reduction of Thromboxane B2 (A and B) and Prostaglandin E2 (C and D) is not altered by the intake of Bif195. AUC (area under the curve).

Prostaglandin E2 (PGE2) and thromboxane B2 (TXB2) are resulting products of the cyclooxygenase enzyme which is inhibited by aspirin. As expected PGE2 and TXB2 are both reduced during the trial due to the intake of low-dose aspirin. Oral administration of Bif195 does, however, not interfere with the aspirin-induced reduction of serum PGE2 and TXB2. Thus, Bif195 do not counteract the intended beneficial effect of aspirin.

Furthermore, in the clinical study, we did not observe any adverse events related to the intake of the study product, indicating that Bif195 do not cause any safety concerns.

Our conclusion from the trial is that Bifidobacterium breve, Bif195 confers clinically significant and objectively verifiable protection against small-intestinal enteropathy caused by aspirin in humans.

Bif195 is an excellent example of a new innovative probiotic product, being a dietary supplement that is safe and very relevant for human health. Bifidobacterium breve Bif195 will be marketed as Galenex^TM.