2021 Patient Education & Advocacy Summit Q&A

Some clinical trials offer remote options. See clinicaltrials.gov to find a study you can participate in remotely.

Dr. Leon: I would say the earliest could be larazotide in ~2023-2024 for the symptoms of celiac disease (not for celiac disease itself) if the study is positive and the FDA was to accept just a single phase 3 trial. If a second phase 3 trial is required (normally that’s the case), then ~2026-2027.

For PRV-015/AMG 714, if all went well it could be approved in ~2026 for the treatment of celiac disease. We believe PRV-015 could be the first drug approved for the treatment of celiac disease.

So ~2026, or ~5 years from now would be the minimum if things go well with the trials.

The phase 3’s mentioned above could include adolescents and kids down to ~12 years of age. For younger kids, a few years later.

Dr. Leon: Here we need you to tell us. We will pay for lost wages, transportation, write a letter to the employer, try to work with sites to open late or even on week-ends, hire at-home services, etc… whatever we can do.

Many people don’t know half the visits in PROACTIVE, our trial, can be done at home! We have a mobile fleet of trial staff. That’s the future. We could do an article about this if you think it’d be of interest.

Dr. Leffler: Definitely! There are lots of types of celiac disease studies and some look particularly for patients with well controlled celiac disease or have specific other disorders as well as celiac disease. One common type of study which requires participants to have no or minimal ongoing symptoms are studies that involve gluten exposure to understand how the immune system responds to gluten, which we are still learning about.

Ms. Neff: 

• To ensure their disease is well-controlled and their small intestine is healed (as reflected by serology lab results) when they enter the study
• To minimize baseline symptoms related to celiac disease which allows easier identification of potential symptoms related to the study drug and/or study gluten challenge
• Patients who have been on a GFD for at least a year are better at managing the gluten free diet and are less likely to encounter gluten inadvertently which helps “reduce the noise” in the study and allows for a better assessment of the study drug

Dr. Leon: To ensure stability of the disease, typically 6-12 months of GFD is required. It’d be very difficult to prove efficacy of an experimental medication in the first 6 months post initiation of a GFD, as the GFD will induce such benefit by itself. The definition of non-responsive celiac disease requires 6-12 months (Rubio-Tapia 2013). And payers wouldn’t reimburse for a drug unless the diet has been ineffective for a while.

The FDA requires that clinical trials study adults first before moving into adolescent studies.

ImmunsanT announced in June of 2019 that it ended its global Phase 2 RESET CeD clinical trial for its Nexvax2 drug candidate. Early results indicate that the drug, which is designed to protect celiac disease patients from gluten exposure, worked no better than a placebo. You can read more here.  

Dr. Leffler: Dermatitis herpetiformis is currently felt to be a direct manifestation of the immune reaction to gluten that begins in the intestine. For this reason, one would expect that a treatment that prevents the reaction to gluten would also be helpful in controlling or preventing dermatitis herpetiformis. However, this would need to be tested and dermatitis herpetiformis may respond better to some types of therapies. I would hope that after approval of a medication for celiac disease, it will be tested in people with different subtypes of celiac disease including dermatitis herpetiformis.

Dr. Leffler: This is hard to compare, but in general funding for celiac disease research has been better in Europe compared with the US. The celiac research community, like the patient community, is very collaborative and there are many excellent examples of cross-border research collaboration.

Research in celiac disease and other autoimmune disorders often overlap, as some patients have multiple autoimmune diseases. This is seen in the TEDDY and DAISY studies, cohort studies following children at risk of developing Type I diabetes, that ended up producing findings related to celiac disease as well. 

Many researchers see solving celiac disease as a gateway to solving other autoimmune diseases. Read more about celiac disease and associated autoimmune disorders here.

This brochure provides details on how to maintain a gluten-free diet as an elderly celiac patient living in an assisted-living facility.

Dr. Liu: This study only considers the risk of celiac disease in a child eating more gluten compared to other children in the study, and those in the higher intake group had a higher risk at the younger age. It’s best to avoid emphasizing the actual grams of gluten because it varies by day and as a child gets older, but the general rule appears to be true: more gluten at a young age seems to increase risk.

Dr. Lebwohl: Inflammation in the intestine can result in a disrupted barrier lining of the intestine, though the term “leaky gut” does not have a clear definition, nor are there reliable tests for that. As for probiotics, there are very limited data suggesting that probiotic use might improve symptoms in people with celiac disease, but this is highly uncertain. As such, and given the lax regulatory framework surrounding supplements (including probiotics), no major professional celiac disease guidelines recommend their use.

Dr. Liu: It’s hard to truly determine, but one recent study suggested that in individuals with celiac disease, nearly 1/3 will have another autoimmune condition, with of course, autoimmune thyroid being the most common.

Dr. Silvester: The generally recognized threshold for gluten in “gluten-free” foods is 20 ppm, so foods containing less than 20 ppm gluten may be labelled “gluten-free” (even if they contain up to 19 ppm gluten). The important thing to remember is that 20 ppm – parts per million – is a concentration, not an amount. So, there is the same amount of gluten in a 20 gram (~2/3 ounce) with 20 ppm gluten as there is in one 200 mg pill with 2000 ppm gluten. The original selection of 20 ppm was based upon the sensitivity (how low levels could be detected) in available tests more than any knowledge of what is “safe” for people with celiac disease. Likely there are some people who are more sensitive than others; however, most people with celiac disease eat “gluten-free” products containing <20 ppm gluten and feel well.

Dr. Lebwohl: Though a gluten challenge can cause discomfort and gut inflammation in the short term, there is no evidence to suggest that a gluten challenge carries long-term risk. The fact that the great majority of patients with celiac disease have a normal life expectancy and that the excess risks of certain cancers decline over time after adoption of the gluten-free diet support the notion that gluten-challenge does not carry adverse effects beyond the short-term.

See information on celiac disease and mental health here, and a study on the psychological symptoms of childhood celiac disease here.

Dr. Lebwohl: Most people with celiac disease and depression and anxiety do not have an identifiable nutritional deficiency as the cause of those symptoms. But it is appropriate to test for vitamin and mineral deficiencies that can sometimes contribute to or exacerbate psychiatric symptoms. For instance, iron deficiency can impact energy levels, and B12 deficiency can cause a variety of neurologic or psychiatric symptoms if there is a severe deficiency. Both can be repleted, sometimes with oral medications and sometimes with injections; this should be done under the supervision of a physician.

According to the North American Society for the Study of Celiac Disease (NASSCD), most experts concur that oats uncontaminated by wheat, barley, and rye can be safely consumed by most people with celiac disease. The statement asks that food manufacturers who are using “commodity” oats (oats not produced under a strict protocol to ensure they are gluten-free), but instead are scrubbing gluten from oats using mechanical and optical processes, use “consistent, stringent, transparent and reliable testing methods to ensure that the end product is gluten-free. Read the NASSCD statement on oats here, and further studies on oats and celiac here.

Dr. Lebwohl: There are a variety of causes, including most commonly inadvertent gluten exposure, concurrent irritable bowel syndrome, additional food intolerances, intestinal infections, and other less common conditions that can be uncovered with additional testing such as microscopic colitis or inflammatory bowel disease.

Dr. Silvester: Symptoms on a gluten-free diet can occur for many reasons – and may not be related to gluten. Studies that were done in conjunction with the Nexvax2 trials and those we have done with gluten detection have been very revealing. We found that milligram amounts of gluten did not generally elicit symptoms and that patients were not exposed to gluten when they thought they were. In the Nexvax2 studies, those who had symptoms often did not have the symptoms that they thought they would have. It appears that nausea and vomiting are likely the most specific symptoms of gluten exposure, and this is related to the immune activation that is triggered by eating gluten in people with celiac disease. In our clinic, we try to make sure that there are no unrecognized gluten exposures (in both children and adults, so-called “non-responsive” symptoms are attributed to gluten about 30% of the time) and also look for other causes, such as irritable bowel syndrome, constipation, or gastroesophageal reflux. There is a longer list for adults.

Dr Lebwohl: Symptoms are not a consistently reliable predictor of ongoing gluten exposure, and there are people without symptoms who still have intestinal damage. Persistent intestinal damage has been linked to an increased risk of lymphoma and fracture in the long-term.

Dr. Lebwohl: A number of cancers have been linked to celiac disease, and lymphoma and cancers of the gastrointestinal tract (including a rare form of small intestinal cancer) are particularly increased in celiac disease; those risks decrease over time after diagnosis.

Those with medical experience can help the celiac community in a number of ways. You can become a State Advocacy Ambassador to urge your Members of Congress to support policy priorities important to the celiac community. Having a medical background can add even more weight to your celiac story. Someone with medical experience can also be an advocate for celiac disease patients in their workplace by educating coworkers on celiac disease. Registered dietitian nutritionists can help by completing a Certificate of Training in Gluten-Related Disorders. Medical professionals with experience treating celiac disease patients can also join our Healthcare Practitioner Directory, to help celiac patients find you when they are looking for a physician that understands their needs as a celiac patient.

Our Healthcare Practitioner Directory lists if a practitioner is a Celiac Disease Unit Recognition Program (CDURP) participant, is a Celiac Disease Foundation Medical Advisory Board member, practices at a Celiac Disease Center/Program, or has Continuing Education in Celiac Disease. These practitioners have demonstrated a greater familiarity with celiac disease than those without such a designation.

Dr. Lebwohl: The rate of villus healing varies greatly between individuals, but among adults it takes an average of 2-3 years for villi to heal. This process is more rapid in children, and there are some people (adults and children) who heal within a few months.

See the Online Guide for Pediatric Celiac Disease here.

Dr. Silvester: There are very clear connections between stress (both physical and psychological) and gastrointestinal health and it is likely a two way relationship (stress may cause gastrointestinal symptoms and vice versa). It is unclear what exactly triggers celiac disease; however, there are definitely strong links between physical and psychological stress and trauma and overall health. Events in childhood have impacts that last through to adulthood. These effects involve how the immune system responds, and may impact risk of developing autoimmune diseases or celiac disease.

Dr. Liu: There certainly is a link between stress that the body experiences (mental and physical) and the immune system. It certainly is hypothesized that stress can impact the development of celiac disease, and is being studied as a factor for example, in the TEDDY study. However, it certainly isn’t going to do this alone, but would be just one additional factor that likely increases risk. In other words, the environmental triggers for celiac disease are likely multifactorial, and none of them to date are as important as the known genetic factors. In terms of stress reduction and GI health, absolutely there is an association. Take irritable bowel syndrome, for example. We know that the guts act up even more when people are nervous, anxious. There is certainly a link between stress/anxiety and how the GI system behaves. But that is different from for example, how stress might affect the immune system!

For questions on celiac disease testing and diagnosis, please see here.

A skin biopsy is used to confirm a diagnosis of Dermatitis Herpetiformis. Read more here about DH diagnosis and treatment.

Researchers are still exploring triggering events of celiac disease, but they believe that environmental, genetic, and immunological factors have a role in the development of celiac disease. Read more here. 

Dr. Silvester: All the celiac antibody tests that are available are only approved for use to diagnose celiac disease and perform reasonably well as screening tests. Once patients with celiac disease go on a gluten-free diet, the immune system is not being stimulated as strongly and the antibody level tends to go down. How long this takes is variable and it is not clearly related to ongoing gluten ingestion. So called “gluten challenge” studies in which altruistic volunteers with celiac disease eat gluten so that we can learn more about how the body reacts have shown that these tests are not very sensitive (may not go from negative to positive) even to relatively large amount of gluten ingestion and it can take many weeks for the level to go up even if gluten is no longer being eaten. On the other hand, when Dr. Murray at Mayo looked at his patients, he found that those with an undetectable TTG IgA were more likely to have normal villi. These tests are often used in practice to follow-up patients with celiac disease because they are the blood test we have and can be helpful in rare cases where they “seroconvert” from negative back to positive as this typically signals a problem.

For information about genetic testing, see here.

The Society for the Study of Celiac Disease has released a statement on the COVID-19 vaccine. Read it here.

State Advocacy Ambassadors must complete the iAdvocate State Advocacy Ambassador Training, which takes 2-3 hours. From there, Advocacy Ambassadors can commit as much or as little time as they want. If you want to be more involved, you can set up a meeting with your Members of Congress. If you want to be less involved but still wish to participate in advocacy, you can send an email to your Members of Congress or post an informative graphic on social media to educate your followers about celiac disease. How much time you choose to commit is up to you, and there are activities for every level of involvement.

Our Social Media Toolkit contains tips and sample captions you can post to raise awareness of celiac disease and encourage others to get involved.

Our Take Action Center has the two items we are currently asking Members of Congress to support: NIH funding for celiac disease research, and the Gluten in Medicine Disclosure Act of 2021. You can send an email to your Members of Congress in support of these priorities here. Our Policy Priorities page contains a more extensive list of all policy priorities we are working on for the celiac community, including both current and future efforts.

When you tell your celiac story to Congress, you should do it with your “asks” in mind, so you can tie your story into them. If you are asking them to support the Gluten in Medicine Disclosure Act of 2021, the Medical Nutrition Therapy Act of 2021, or NIH funding for celiac disease research, the end goal is for them to support these efforts. Make sure to tie your celiac story into why these policies are important for celiac patients.

We encourage State Advocacy Ambassadors to be involved in both local and federal legislation.

Anyone can be an advocate for the celiac community, regardless of diagnosis status. When advocating to Members of Congress and telling your celiac story, you could mention how you are not diagnosed yet and share any struggles you may have faced to get diagnosed, i.e. waiting to be diagnosed, being misdiagnosed by a physician, having to undergo a gluten challenge to be diagnosed, etc.

Illustrating all aspects of living with celiac disease will make Members of Congress more aware of what people with celiac go through on a daily basis. Making them understand the barriers to get diagnosed as a celiac patient is a part of this.

For the Gluten in Medicine Disclosure Act of 2021, you can check the list of cosponsors here to see if your Member of Congress is signed on. This bill was recently introduced, so you can check if your Member of Congress was a cosponsor of the 2019 version of the Gluten in Medicine Disclosure Act for the House or Senate versions. Members of Congress who cosponsored the 2019 Gluten in Medicine Disclosure Act are likely to sign-on as cosponsors once more. If you see your Member of Congress was a cosponsor of the 2019 bill, thank them and inform them that the bill has been introduced once more and needs cosponsors. If they didn’t cosponsor the 2019 bill, use our Gluten in Medicine Leave Behinds in the Advocacy Toolkit on iadvocate.celiac.org to explain why they should support this important legislation for celiac patients.

For the Medical Nutrition Therapy Act of 2021, you can find the list of cosponsors for the Senate version here and the House version here. This bill was also recently introduced, so you can see the cosponsors of the 2020 Senate and House versions of this bill to see if your Member of Congress supported it.

For other policy initiatives, such as NIH funding for celiac disease research and including celiac disease in the Congressionally Directed Medical Research Programs (CDMRP), contact your Member of Congress to find out if they support these efforts. Find contact information for your Senator and Representative.

To bring celiac disease to the forefront of national attention, we need the patient community to be vocal about the everyday struggles of living with celiac disease. In order for anything to be done about celiac disease, Members of Congress must know that this is a disease affecting millions of Americans, for which there is no cure. Compel your Members of Congress to take celiac disease seriously by contacting them and their staff and sharing your story as a celiac disease patient or caregiver.

DC elects a non-voting Delegate to the US House of Representatives who can draft legislation but cannot vote. The current Delegate for DC is Congresswoman Eleanor Holmes Norton. Even though Congresswoman Norton cannot vote on bills, she can still draft legislation, sit on Committees and Caucuses, and cosponsor bills- making DC representation just as important to our policy priorities as any other representative.

Members of the House Committee on Appropriations can be found here. Find information about your Senator and Representative, and see if they are a member of the House Committee on Appropriations. The House Committee on Appropriations is responsible for funding the federal government’s vital activities such as education, healthcare, and infrastructure. This Appropriations Committee is also responsible for determining National Institutes of Health (NIH) funding. 

Beginning with CEO Marilyn G. Geller’s testimony before the House Appropriations Subcommittee in April of 2019, the Celiac Disease Foundation has worked to secure FY2020 and FY2021 Appropriations report language directing the NIH to devote sufficient, focused research to the study of celiac disease. Contact your Members of Congress here to urge them to continue to support this important research funding for celiac disease.

Currently, the Celiac Caucus is comprised of Representatives Betty McCollum (MN-04), and Tim Ryan (D-OH).

Chair, Representative Betty McCollum (MN-04) is working to prepare the Congressional Celiac Caucus for launch, of which Tim Ryan (D-OH), is also a member. Plans for the Celiac Caucus are still underway. Once another co-chair is secured, in addition to Representative Betty McCollum (MN-04), the Caucus will have bipartisan support and will be ready for launch. We look forward to sharing with you how you can urge your Members of Congress to join the Congressional Celiac Caucus.

Once the Celiac Caucus is launched and has two co-chairs, a template letter will be posted in the Take Action Center at celiac.org to send to Members of Congress and encourage them to join the Caucus. Keep an eye out for an email announcing the launch of the Caucus! 

On April 8, 2021, Representatives Tim Ryan (D-OH) and Steve Stivers (R-OH) introduced the Gluten in Medicine Disclosure Act of 2021. The bill, H.R.2435, intends to make it easier to identify gluten in prescription medications.

The Celiac Disease Foundation has been working with Rep. Ryan’s staff since 2012 on the need for labeling of gluten in medication. In 2019, Rep. Ryan and Rep. Tom Cole (R-OK) introduced similar legislation which, thanks in part to the commitment of our celiac patient community, secured 53 co-sponsors. The bill was not brought before Congress for a vote in 2020. This year, we are optimistic that if we can rally the celiac community again, we can advance this legislation through the process. 

Please take one minute to email your Members of Congress and urge them to cosponsor this important legislation to make it easier and safer for individuals with celiac disease to make informed purchases of needed medications.

In the meantime, while this bill is being brought before Congress, to ensure your medications are gluten-free, we recommend reaching out to the manufacturer or checking Medline Plus or DailyMed, found here.

Cosponsors of the House Gluten in Medicine Disclosure Act of 2019 can be found here. The Senate version can be found here. The Gluten in Medicine Disclosure Act of 2021 has been introduced in the 117th Congress with a new bill number, H.R.2435.

It would absolutely be helpful to call and thank the cosponsors of the 2019 bill if you are in their district. Now that the bill has been reintroduced in the new Congress, these cosponsors will need to be secured once more. Members of Congress who cosponsored the 2019 Gluten in Medicine Disclosure Act are likely to sign-on as cosponsors once more. Check if your Member of Congress was a cosponsor of the 2019 bill. If they were, thank them and inform them that the bill has been introduced once more and needs cosponsors. If they didn’t cosponsor the 2019 bill, use our Gluten in Medicine Leave Behinds in the Advocacy Toolkit on iadvocate.celiac.org to explain why they should support this important legislation for celiac patients.

The Medical Nutrition Therapy Act of 2020 aims to extend Medical Nutrition Therapy to a variety of conditions including celiac disease, prediabetes, obesity, high blood pressure, high cholesterol, malnutrition, eating disorders, cancer, HIV/AIDS, and unintentional weight loss.

On May 10 and May 11, the Medical Nutrition Therapy Act of 2021 was introduced by Representatives Robin Kelly (D-IL) and Fred Upton (R-MI), and Senators Susan Collins (R-ME) and Gary Peters (D-MI). The Medical Nutrition Therapy Act of 2021 extends Medicare coverage of dietitian visits to celiac patients and other patients with chronic conditions. Please take one minute to email your Members of Congress and urge them to cosponsor this bill to support coverage of medical nutrition therapy for celiac patients. 

Contact your Members of Congress and urge them to support NIH funding for celiac disease research. You can send a pre-written email to your Members of Congress through our Take Action Center, schedule a virtual visit and utilize the leave behinds in our Advocacy Toolkit to convey the need for NIH funding, or tag your Member of Congress in a post using the tips and sample captions in our Social Media Toolkit.

The most recent development in securing NIH funding for celiac disease occurred on March 18, 2021, with the NIH’s Accelerating Progress in Celiac Disease Workshop. This workshop is a direct outcome of our advocacy efforts in Washington, DC, in particular the inclusion of report language in NIH’s appropriation budget by our legislative partners on Capitol Hill. It is anticipated that an important outcome of the Workshop will be the issuance by NIH of a Notice of Special Interest for celiac disease. An NIH Notice of Special Interest describes “research topics in a specific scientific area… and points to active funding opportunity announcements (FOAs) through which investigators can apply for support”. This is a huge opportunity for celiac disease researchers to access federal biomedical research funding- and we must keep the momentum going by urging Members of Congress to support NIH funding for celiac disease research.

NIH funding across the various gastrointestinal diseases was examined in the 2017 study, “Disparities Among Gastrointestinal Disorders in Research Funding From the National Institutes of Health.” Researchers concluded that trends in NIH funding of the 6 different GI diseases remained relatively stable over the 5-year period.

Crohn’s disease was consistently awarded the highest amount of money, at approximately $16 million per year. Crohn’s disease was followed by Barrett’s esophagus at approximately $13 million per year, NAFLD at approximately $7 million per year, IBS at approximately $5 million per year, and EoE at approximately $4 million per year. Celiac disease consistently received the lowest amount of NIH funding over the 5-year period, at approximately $3 million per year.  Celiac disease consistently received the lowest amount of NIH grants, at approximately eight grants per year.

There was no association found between NIH funding and estimated disease prevalence in the United States. EoE had the lowest prevalence at 0.04%, and received the second lowest amount of NIH funding over the 5-year period at $18.9 million. Crohn’s disease, with the second lowest prevalence of approximately 0.25%, received the highest amount of funding from 2011 to 2015 at $77.5 million. Barrett’s esophagus, with a prevalence of approximately 1%, received $64.1 million over the 5-year period. Celiac disease, with prevalence very similar to that of Barrett’s Esophagus at approximately 1%, received significantly less funding over the 5-year period at $15.4 million—the lowest amount of all the diseases studied. 

Dr. Leffler: This is hard to compare, but in general funding for celiac disease research has been better in Europe compared with the US.  The celiac research community, like the patient community, is very collaborative and there are many excellent examples of cross-border research collaboration.

For questions regarding 504 plans, click here.

Dr. Lebwohl: There is data suggesting that the gluten-free food market is large and growing. There are also studies of the economic impact of celiac disease, showing excess costs, some of which persist after diagnosis, as well as studies showing that gluten-free food items are more expensive than their gluten-containing counterparts.

Celiac disease does qualify as a disability under the Americans with Disabilities Act, and celiac patients can qualify for unemployment. Learn more about your unemployment benefits here.