FeaturesAugust/September 2017 Issue

AN-PEP Enzymes: Protection from Gluten Contamination

The AN-PEP enzyme may be great news for many with celiac disease or gluten sensitivities

Eating out can feel like stepping onto a minefield of hidden gluten. Even if you’re super vigilant about your gluten-free diet, there can be accidental exposure. What if there were a pill to keep you safe from cross-contamination?

Enter the AN-PEP enzyme, a promising digestive enzyme that can break down gluten. A new study presented at the Digestive Disease Week conference in May shows that the AN-PEP enzyme (aspergillus niger-derived prolyl endoprotease) can degrade gluten in the stomach, although researchers caution the enzyme is not intended to treat or prevent celiac disease.

Over the past few years, several journal studies have indicated that AN-PEP may be effective in degrading gluten into small, harmless fragments. This new study out of Örebro University in Sweden monitored 18 gluten-sensitive participants who ate a porridge containing crumbled wheat cookies. Results showed that AN-PEP significantly lowered gluten levels in participants’ stomachs and small intestines.

“These results suggest that AN-PEP can potentially be used when gluten-sensitive individuals [are concerned they might] unintentionally consume foods with a small amount of gluten, so they can feel safer with their food choices,” says researcher Julia König. “We are not suggesting that AN-PEP will give gluten-sensitive individuals the ability to go out and eat large amounts of gluten, such as a whole bowl of pasta.”

The study did not test AN-PEP on people with celiac disease “because even a small amount of gluten can cause long-term harm for these patients,” König explains. “We just cannot be 100 percent sure that it degrades all the gluten. That’s why we say that celiac patients should still be on a strict gluten-free diet.”

Those with celiac disease can use the enzyme to be extra safe to avoid cross-contamination. They should not use it to start eating food that contains gluten, König says.

Gluten Degradation in the Body

Let’s back up. Why does gluten need to be broken down or degraded?

Gluten is made up of glutenin and gliadin proteins. The human gastrointestinal system is not able to break down gliadin effectively and long fragments can reach the small intestine. For most people, these fragments aren’t a problem and they pass through the body.

girl taking pill

© Shutterstock/pretty vectors

But in celiac disease, the long fragments get through a leaky gut and pass into blood circulation. There, HLA-DQ2 and HLA-DQ8 molecules (related to the genes present in celiac disease) bind to these fragments, setting off a T-cell inflammatory attack. AN-PEP breaks down the long gliadin proteins into smaller fragments in the stomach—before they reach the small intestine. Too small now to bind to the HLA-DQ molecules, these degraded proteins can’t cause harm.

Seeking Solutions to Accidental Gluten Exposure

Manufactured by Dutch company DSM, AN-PEP is now available in the United States as a food supplement called GliadinX. Introduced in March, GliadinX contains a high level of AN-PEP (335 milligrams per capsule) plus an agent to lower its pH, as research has shown the enzyme works better in a more acidic environment, says GliadinX founder Albert Zickmann.

Because it’s sold as a food supplement, GliadinX has not undergone FDA’s testing and approval process and cannot be marketed to treat or prevent a disease. It’s designed to be an adjunct to the gluten-free diet to address cross-contamination or incidental exposure to gluten, but Zickmann sees a potential for wider use.

“Based on available data, a lot of people with celiac disease and those with non-celiac gluten sensitivity might benefit from taking GliadinX,” he says. “It might be able to take care of not only cross-contamination but also overt gluten—but further research is necessary.”

The enzyme may also help prevent damage in those noncompliant with the gluten-free diet, Zickmann adds. (Dietary compliance rates vary widely but generally are lower than 50 percent, according to a 2013 Mayo Clinic study.)

Like a Lactaid enzyme that breaks down lactose, GliadinX capsules are taken immediately before eating gluten-containing food. Dosage varies based on type of foods ingested and portion size, making self-dosing difficult. There are no known side effects from the enzyme and no maximum dose has been established, Zickmann says.

If gluten is ingested and symptoms are already evident, GliadinX will not be effective, he says. He cautions that GliadinX might not work well for some people with non-celiac gluten sensitivity or non-celiac wheat sensitivity. That’s because some people may be reacting to other aspects of wheat, such as fructans or amylase trypsin inhibitors, and not gluten. Similarly, the enzyme is not effective for wheat allergy.

AN-PEP is Not a Cure

Frits Koning, PhD, has worked with DSM and studied AN-PEP at Leiden University in the Netherlands, authoring several AN-PEP studies. “My message to celiac patients is that this is a very nice enzyme in case you feel unsafe. If you go out for dinner or you’re on holiday and you fear you may come in contact with gluten unwillingly or unknowingly, then you can take this enzyme prior to your meal as a precaution,” he says. “The enzyme is quite good at degrading gluten but, in my opinion, it will never allow celiacs to start a gluten-containing diet.”

Koning points to the large number of capsules that would be necessary to degrade gluten in a regular diet and the fact that there may be some variability in the enzyme’s efficacy, due to pH levels and other foods consumed.

The new Swedish study showed that gluten levels in the stomach were 85 percent lower in those taking AN-PEP than in the placebo group. But Koning says that’s not enough for someone with celiac disease.

“If you eat 1 gram of gluten and you destroy 80 percent, it is still way above the 20 ppm limit” for safe gluten consumption, he says. “If you really want to guarantee safety, you have to destroy 99 percent. That’s really hard to achieve with enzymes, unless the quantity of gluten is really low. Everything depends on the level of gluten that you eat. If your gluten exposure is high, you have to destroy more to get into a safe zone. If the gluten contamination is in the order of milligrams, then you just have to reduce a limited amount and you’re safe. If you feel you’re at risk, you can use the enzyme to minimize the risk but not exclude it. There’s no guarantee that you’ll destroy enough of the gluten—but you’ll certainly destroy some of it because the enzyme will do its job.”

While the AN-PEP enzyme degrades gluten, it’s not a cure for celiac disease, emphasizes Stefano Guandalini, MD, founder and medical director of The University of Chicago Celiac Disease Center. However, it can be useful to counter gluten cross-contamination when eating out or traveling as a support for the gluten-free diet, he says.

“I strongly caution against having a false sense of security when using this enzyme product,” Guandalini says. “Although it’s effective in delivering what it claims, it must only be considered an extra layer of protection against minor cross-contamination in patients who need to observe a gluten-free diet.” He recommends that patients who take the enzyme be monitored by their doctor with periodic blood tests.

More research is needed but it appears that AN-PEP may be able to break down incidental gluten and degrade the worries of those on a gluten-free diet.

Associate editor Eve Becker is a health writer. Her daughter has celiac disease.

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