On May 11, 2015, the Food and Drug Administration (FDA) will conduct a public meeting on Functional GI Disorders Patient-Focused Drug Development. The FDA is interested in obtaining patient input on the impact of functional GI disorders on daily life and patients’ views on currently available therapies to treat the functional GI disorders, such as irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation.

While celiac disease is not known as a Functional GI disorder, Celiac Disease Foundation was requested by the FDA to provide commentary about the impact of celiac disease on patients’ daily lives, the types of treatment benefit that matter most to patients, and patients’ perspectives on the adequacy of the available therapies. The commentary below was provided on behalf of the celiac patient population in advance of the public meeting.

Patient-Focused Drug Development Comment Summary

To more comprehensively reflect the patient perspective in anticipation of the Functional GI Disorders public meeting, Celiac Disease Foundation posed the topic questions to our community via an online survey. We received over 1,000 completed surveys in under one week. Clearly, our respondents will be among the more engaged and proactive of the population diagnosed with celiac disease. From our survey, we learned the following:

  • 90 percent of the respondents were female. More than 93% were adults. 90 percent of the respondents reported being diagnosed with celiac disease by a health care provider. In a 2013 study of adult celiac disease presented at a University in Naples, Italy, the ratio of women to men was 3.33.[1]
  • 45 percent of survey participants reported it took five years or more after symptoms presented to receive their diagnosis of celiac disease. Only 21% were diagnosed in the first year.
  • 21 different symptoms were reported by our respondents as having a significant impact on their life. Half cited abdominal pain, and slightly less than that cited fatigue. Chronic diarrhea and bloating ranked high, as did brain fog for more than 27% and depression or anxiety for more than 25%.
  • Even though 85% report that their symptoms have improved since adopting a gluten-free diet, 54% report that there are specific activities that are important to them that they cannot do because of the disease.
  • It is clear that the anxiety about accidental gluten exposure outside the home is the single most constraining factor about living with the disease. More than 80% feel limited eating outside the house, and more than 56% find travel difficult.
  • More than 60% report that the high cost of gluten-free foods is a financial burden.
  • Almost 70% report that symptoms last three days or longer after exposure to gluten. More than 8% report that symptoms last 14 days or more.
  • 40 percent report missing school/work days due to symptoms.
  • When asked what worries them most about celiac disease, 68% are concerned that celiac will cause other health problems (research has established links to small bowel malignancy, especially lymphoma and bone health[2], and comorbidity with numerous other autoimmune diseases are documented[3]); 63% are concerned about the impact of celiac disease on their long-term health.

Our community lives in fear of accidental exposure to gluten, especially outside of the home in environments they do not or cannot control. There is also the possibility of accidental ingestion of gluten from poorly labeled or mislabeled products. And based on their reporting, their fear is well-justified given that, for the overwhelming majority, symptoms from exposure last more than three days. Therapies that can treat accidental exposure are a high priority.

Children were not well-represented in our survey and they present a different set of treatment challenges that may be addressed by drug therapy. There is evidence that strict adherence to a gluten-free diet is more difficult for children, and that adherence may decline as children get older.[4][5]

Chief Executive Officer, Marilyn G. Geller will be attending the FDA public meeting to present the Celiac Disease Foundation findings on behalf of the celiac patient population.

View the Survey Results


[1] Scand J Gastroenterol. 1995 Nov;30(11):1077-81.
Gender and clinical presentation in adult celiac disease.
Ciacci C1, Cirillo M, Sollazzo R, Savino G, Sabbatini F, Mazzacca G.

[2] Pathologe. 2015 Mar 28. [Epub ahead of print]
Histological diagnosis and complications of celiac disease: Update according to the new S2k guidelines.
[Article in German]
Aust DE1, Bläker H.

[3] BMC Med. 2014 Feb 25;12:34. doi: 10.1186/1741-7015-12-34.
Autoantibodies against MHC class I polypeptide-related sequence A are associated with increased risk of concomitant autoimmune diseases in celiac patients.
López-Vázquez A, Mozo L, Alonso-Arias R, Suárez-Álvarez B, Vidal-Castiñeira JR, Arranz E, Volta U, Bousoño C, López-Hoyos M, Rodrigo L, López-Larrea C1.

[4] Digestion. 2012;86(4):309-14. doi: 10.1159/000341416. Epub 2012 Oct 23.
Factors associated with dietary adherence in celiac disease: a nationwide study.
Kurppa K1, Lauronen O, Collin P, Ukkola A, Laurila K, Huhtala H, Mäki M, Kaukinen K.

[5] Eur J Clin Nutr. 2013 Jun;67(6):615-9. doi: 10.1038/ejcn.2013.54. Epub 2013 Mar 6.
Determinants of adherence to gluten-free diet in Greek children with coeliac disease: a cross-sectional study.
Charalampopoulos D1, Panayiotou J, Chouliaras G, Zellos A, Kyritsi E, Roma E