Enzyme tablet may protect gluten-sensitive patients from exposure

CHICAGO — The enzyme known as aspergillus niger-derived prolyl endoprotease, or AN-PEP, shows promise for protecting gluten-sensitive patients from experiencing symptoms after exposure to small amounts of gluten, according to research presented at Digestive Disease Week.

“People with gluten sensitivity usually try to carefully avoid gluten and they control every part of their diet. However, sometimes they unintentionally eat foods that contain small amounts of gluten,” Julia König, MD, of the Nutrition-Gut-Brain Interactions Research Center at Örebro University in Sweden Örebro, Sweden, said during a press conference. “Based on findings from our research, these individuals may be able to prevent and find relief from these situations from using the enzyme tablet that degrades gluten in the stomach before it enters the duodenum.”

Julia König

A previous study showed AN-PEP (Tolerase G, DSM) degraded gluten as part of an artificial liquid meal introduced into the stomach through a feeding tube, König added, so her study is the first to test the enzyme in a more normal physiological meal setting.

She and colleagues performed a randomized, double blind, placebo-controlled crossover study of 18 individuals who reported they were gluten-sensitive. On 3 test days, all participants were randomly assigned to consume a porridge containing about 0.5 g of gluten along with two tablets containing a high dose of AN-PEP (160,000 PPI), a low dose of AN-PEP (80,000 PPI) or placebo.

Investigators sampled participants’ gastric and duodenal contents using a multilumen nasoduodenal feeding catheter several times over 180 minutes, and used the Gluten-Tec ELISA to analyze samples for gluten epitopes. Patients also reported their symptoms by questionnaire after each test day.

König and colleagues found that both the low dose and high dose tablets reduced gastric gluten concentrations by 85% compared with placebo (P = .001 for both). Further, the low dose tablet reduced duodenal gluten concentrations by 87% (P = .019) and the high dose reduced them by 81% compared with placebo (P = .015).

“The study also highlights [that] AN-PEP works effectively in low pH acidic conditions such as those found in the stomach. This is an important feature as other gluten-degrading enzymes are often not active in acidic environments,” König said during the press conference. “These results suggest that AN-PEP can potentially reduce the side effects that occur when gluten sensitive individuals unintentionally consume foods with small amounts of gluten, so they can feel safer with their food sources.”

Importantly, König emphasized that the study results do not suggest the enzyme will give gluten-sensitive individuals the ability to safely eat large amounts of gluten, and AN-PEP is not intended to treat or prevent celiac disease. The investigators did not test the enzyme in patients with celiac disease as even small amounts of gluten can cause long term-harm in these patients.

AN-PEP is available in the U.S. as a supplement, and the manufacturer, DSM, provided the enzyme for the study but did not provide any other support, according to a press release. – by Adam Leitenberger

Reference:

König J, et al. Abstract Su1137. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosures: König reports no relevant financial disclosures.