A Pill to Treat Celiac Disease Could Be Coming Soon

There’s exciting news on the horizon for anyone who suffers from celiac disease — the first medical treatment for the condition may be entering clinical trials as soon as this year. Right now, the only treatment for gluten issues is to avoid consuming any products produced with wheat, barley or rye completely, which can be tricky to accomplish given how widespread wheat products are in modern food production.

This New Treatment Attacks and Destroys Gluten in the Stomach

The new treatment, a synthetic enzyme called KumaMax, is taken as a pill prior to a meal. To understand how it works, you need to know a bit about celiac disease, and how the body normally processes gluten. Simply put, the human body can’t completely break down the gluten protein in the stomach, so it passes relatively unchanged into the small intestine. For most people, this isn’t a problem, and the gluten is effectively ignored by the body. But in celiac patients, the body’s immune system recognizes the protein as a harmful invader, and it mounts an immune response to fight the protein off.

The resulting inflammation damages the lining of the small intestine, usually causing serious digestive issues and other systemic symptoms. A celiac who continues to consume gluten may end up damaging their digestive system so severely that they have trouble absorbing vital nutrients, affecting their overall health and putting them at risk of other autoimmune conditions. Left untreated long enough, gluten exposure can significantly raise the risk of digestive cancers as well.

KumaMax was created by University of Washington researchers with the idea of stopping this inflammatory process before it even starts. The enzyme, when taken with food, breaks down 99.97 percent of the gluten in a meal within about 30 minutes — well before the protein has a chance to enter the small intestine and trigger an immune reaction.

KumaMax Is Not a Cure, But it Can Improve Quality of Life

If you’ve been yearning for a pill that will allow you to consume bagels and pasta with abandon, don’t set your hopes too high. Because KumaMax leaves about 0.03 percent of the gluten in a given meal intact, it’s not yet an effective “cure” for celiac disease. According to Dr. Ingrid Swanson Pultz, the lead researcher on the project, studies show that celiac patients can only safely consume about 10 milligrams of gluten without setting off a reaction — so the amount someone using KumaMax could safely consume in one sitting would be about a gram of the protein. For reference, a slice of high-gluten bread contains about four grams of gluten. So while the reaction to eating a normal sandwich wouldn’t be as severe for a celiac patient on KumaMax, it still wouldn’t allow them to completely abandon the gluten-free diet.

Instead, what KumaMax would allow celiacs to do would be to allow them to more easily eat out or sample prepared foods without worry. Unfortunately, many products that should be naturally gluten-free are often cross-contaminated with gluten proteins, potentially making customers ill. Even products specifically labeled as gluten-free can run into issues — the controversy surrounding the new “gluten-free” line of Cheerios, which was the subject of a recall after sickening at least 125 people, is just the latest example.

While it’s indefensible for a company to advertise a product as being suitable for a specific medical condition when it’s not, General Mills is in a tough situation. The FDA considers only foods with less than 20 parts per million of gluten to be truly “gluten-free” — meaning that even a slight bit of contamination can easily render millions of boxes of product inedible to celiac patients. This is an incredibly common issue with naturally gluten-free foods that are processed or packaged in shared facilities with wheat products. Even minimally-processed foods like dried beans or rice could end up being unsafe if they’re not from a gluten-free facility.

Often, the only safe solution for celiac patients is to seek out brands that have taken the time, effort and expense to have their products certified gluten-free, a process that can significantly raise the price tag in the grocery aisle. While more and more stores are carrying certified gluten-free products in recent years, it can still be incredibly difficult to find some foods without special ordering them. KumaMax could help reduce some of this cost and hassle by allowing people with celiac to purchase items that would normally be a bit risky due to cross-contamination.

It could also help those with celiac overcome the social isolation that often comes along with any food allergy or intolerance. Because it takes so little cross-contamination to set off an immune reaction, it can be very difficult to find something safe to eat at a restaurant that also serves bread, pasta or baked goods. Restaurant employees often don’t realize that people with celiac can’t eat French fries that have been cooked in the same oil as breaded items, or rice pasta cooked in the same water as wheat pasta. As a result, many people with a severe gluten intolerance avoid eating out entirely, or only visit a handful of trusted establishments.

Needless to say, cross-contamination makes it a struggle to attend social events, even those where a “gluten-free” menu is theoretically available. This new medication would eliminate much of the worry for celiac patients and give them more flexibility over where, when and what they can safely eat while maintaining a gluten-free diet.

So Far it’s Only Proven to Help With Celiac Disease, Not Gluten Sensitivity

What about people with non-celiac gluten sensitivity (NCGS)? Unfortunately, it’s not yet clear how well this medication will work. Though the immune reaction behind celiac disease is well-known, scientists still aren’t sure exactly what causes gluten intolerance — or if undigested gluten fragments are even the reason so many people without celiac seem to respond poorly to the protein. In fact, there isn’t even a test to diagnose NCGS yet, because while it causes symptoms similar to celiac, it doesn’t show the same pattern of damage to the small intestine, nor does it come with the same elevated risk of intestinal cancers.

Hopefully, as more testing is done on KumaMax’s effectiveness in humans, we’ll be able to learn more about how people with gluten intolerance respond to the enzyme. If it ends up having the same effect as it does in celiac patients, that could give doctors and researchers some important clues about the causes of NCGS and better options to test for the disease.

When Can We Expect to See the Pill on Store Shelves?

So far, the enzyme has been shown to destroy most gluten in artificial gastric conditions and in rodent models. However, it’s important to remember that as promising as this treatment sounds, it still needs to go through several rounds of testing before it’s deemed safe and effective enough to hit store shelves.

Right now, KumaMax is undergoing toxicity tests to ensure that it’s safe for human use, although Dr. Pultz says that she doesn’t anticipate any problems since the enzyme is created from naturally-occurring amino acids that are already present in the human diet. Once the toxicity study is passed, the next step will be human clinical trials, which may begin within the next year.

Photo Credit: Thinkstock


Jerome S
Jerome S1 years ago


Jim V
Jim Ven1 years ago

thanks for sharing.

Jim Ven
Jim Ven2 years ago

thanks for the article.

Siyus Copetallus
Siyus Copetallus2 years ago

Thank you for sharing.

William C.
William C2 years ago

Thank you.

Mona Pietsch
Mona Pietsch2 years ago


Jim Ven
Jim Ven2 years ago

thanks for the article.

Janet B.
Janet B2 years ago


angela usher
angela U2 years ago

This technology will allow for "slip ups" when dining out or at someone else's home - great breakthrough.

esther w.
e W2 years ago

let's hope so for the sufferors