Digestive Diseases and Sciences

, Volume 62, Issue 5, pp 1277–1285 | Cite as

AGY, a Novel Egg Yolk-Derived Anti-gliadin Antibody, Is Safe for Patients with Celiac Disease

  • Dory A. Sample
  • Hoon H. SunwooEmail author
  • Hien Q. Huynh
  • Heather L. Rylance
  • Cheri L. Robert
  • Bi-Wen Xu
  • Sung H. Kang
  • Naiyana Gujral
  • Levinus A. Dieleman
Original Article



Celiac disease (CD) is a gluten-triggered autoimmune disorder of the small intestine. A lifelong gluten-free diet (GFD) is the only approved treatment; however, strict adherence is difficult and many suffer from inadvertent gluten exposure. Oral egg yolk anti-gliadin antibody (AGY) is a novel treatment to neutralize gluten and may improve the efficacy of the GFD.


To determine the safety, tolerability, and potential efficacy of AGY in patients with CD.


This 6-week, open-label, single-arm study was conducted in adults with biopsy-proven CD on a GFD. Safety measures included adverse events, physical examination, and clinical laboratory tests. Additional measures included a daily Celiac Symptom Index, Health-Related Quality of life, anti-tissue transglutaminase and anti-gliadin IgA/IgG, and lactulose/mannitol excretion ratio (LMER). A 2-week run-in period to assess questionnaire compliance and acceptability of baseline safety laboratory results was followed by a 4-week treatment period with two AGY capsules taken before meals.


Ten patients completed the study (mean age 43.4 years, nine female). All followed a GFD for at least 6 months (mean 5 years). No safety concerns were identified. Most patients had fewer celiac symptoms (especially tiredness, headache, and bloating), improved quality of life, lowered antibodies, and lowered LMER when taking AGY compared to the run-in period.


In our cohort, AGY was safe and potentially associated with improved CD-related outcome measures in patients on a GFD. A larger study powered for further safety and efficacy evaluation is planned.


Anti-gliadin antibody Celiac disease Gluten-free diet AGY 



ALMA Agency Ltd. (Project No. 2007L009R, Edmonton, AB, Canada), and funded by IGY INC (Canada) and VETANDA Group Ltd (U.K.). This research has been facilitated by the Women and Children’s Health Research Institute through the generosity of the Stollery Children’s Hospital Foundation and supporters of the Lois Hole Hospital for Women. Study data were collected and managed using REDCap [23] electronic data capture tools hosted and supported by the Women and Children’s Health Research Institute at the University of Alberta. We thank Prof. Allan Thomson for expert clinical input for the clinical trial.


H.H. Sunwoo has received research fundings from IgY Inc and VETANDA Group Ltd.

Compliance with ethical standards

Conflict of interest



  1. 1.
    Rashid M, Cranney A, Zarkadas M, et al. Celiac disease: evaluation of the diagnosis and dietary compliance in Canadian children. Pediatrics. 2005;116:e754–e759.CrossRefPubMedGoogle Scholar
  2. 2.
    Fedorak RN, Switzer CM, Bridges RJ. Canadian digestive health foundation public impact series 4: celiac disease in Canada. Incidence, prevalence, and direct and indirect economic impact. Can J Gastroenterol. 2012;26:350–352.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Gujral N, Freeman HJ, Thomson ABR. Celiac disease: prevalence, diagnosis, pathogenesis and treatment. World J Gastroenterol. 2012;18:6036–6059.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Kang JY, Kang AHY, Green A, Gwee KA, Ho KY. Systematic review: worldwide variation in the frequency of coeliac disease and changes over time. Aliment Pharmacol Ther. 2013;38:226–245.CrossRefPubMedGoogle Scholar
  5. 5.
    Tran TH. Advances in pediatric celiac disease. Curr Opin Pediatr. 2014;26:585–589.CrossRefPubMedGoogle Scholar
  6. 6.
    Tully M. Pediatric celiac disease. Gastroenterol Nurs. 2008;31:132–140.CrossRefPubMedGoogle Scholar
  7. 7.
    Sapone A, Lammers KM, Casolaro V, et al. Divergence of gut permeability and mucosal immune gene expression in two gluten-associated conditions: Celiac disease and gluten sensitivity. BMC Med. 2011;9:23.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Niewinski MM. Advances in celiac disease and gluten-free diet. J Am Diet Assoc. 2008;108:661–672.CrossRefPubMedGoogle Scholar
  9. 9.
    Lee HJ, Anderson Z, Ryu D. Gluten contamination in foods labeled as “gluten free” in the United States. J Food Prot. 2014;77:1830–1833.CrossRefPubMedGoogle Scholar
  10. 10.
    Koerner TB, Cleroux C, Poirier C, Cantin I, Alimkulov A, Elamparo H. Gluten contamination in the Canadian commercial oat supply. Food Addit Contamin. 2011;28:705–710.CrossRefGoogle Scholar
  11. 11.
    Akobeng AK, Thomas AG. Systematic review: tolerable amount of gluten for people with coeliac disease. Aliment Pharmacol Ther. 2008;27:1044–1052.CrossRefPubMedGoogle Scholar
  12. 12.
    Palaniyappan A, Das D, Kammila S, Suresh MR, Sunwoo HH. Diagnostic of severe acute respiratory syndrome–associated corona virus (SARS–CoV) nucleocapsid antigen using chicken immunoglobulin Y (IgY). Poult Sci. 2012;91:636–642.CrossRefPubMedGoogle Scholar
  13. 13.
    Coleman, MA. Oral administration of chicken yolk immunoglobulins to lower somatic cell count in the milk of lactating ruminants. 1996. (patent, US, Ed).Google Scholar
  14. 14.
    Gujral N, Lobenberg R, Suresh M, Sunwoo H. In-vitro and in vivo binding activity of chicken egg yolk immunoglobulin Y (IgY) against gliadin in food matrix. J Agric Food Chem. 2012;60:3166–3172.CrossRefPubMedGoogle Scholar
  15. 15.
    Tye-Din JA, Anderson RP, Ffrench RA, et al. The effects of ALV003 pre-digestion of gluten on immune response and symptoms in celiac disease in vivo. Clin Immunol. 2010;134:289–295.CrossRefPubMedGoogle Scholar
  16. 16.
    Dauphinee SW, Gauthier L, Gandek B, Magnan L. Readying a US measure of health status, SF-36, for use in Canada. Clin Invest Med. 1997;20:224–238.PubMedGoogle Scholar
  17. 17.
    Porcelli B, Ferretti F, Vindigni C, Scapellaato C, Terzuoli L. Assessment of a combination screening assay for celiac disease. Autoimmun Highlights. 2011;2:67–71.CrossRefGoogle Scholar
  18. 18.
    Burgin-Wolff A, Dahlbom I, Hadziselimovic F, Petersson CJ. Antibodies against human tissue transglutaminase and endomysium in diagnosing and monitoring coeliac disease. Scand J Gastroenterol. 2002;37:685–691.CrossRefPubMedGoogle Scholar
  19. 19.
    Smecuol E, Bai J, Vazquez H, et al. Gastrointestinal permeability in celiac disease. Gastroenterology. 1997;112:1129–1136.CrossRefPubMedGoogle Scholar
  20. 20.
    Wilairatana P, Meddings JB, Ho M, Vannaphan S, Looareesuwan S. Increased gastrointestinal permeability in patients with plasmodium falciparum malaria. Clin Inf Dis. 1997;24:430–435.CrossRefGoogle Scholar
  21. 21.
    Paarlahti P, Kurppa K, Ukkola A, et al. Predictors of persistent symptoms and reduced quality of life in treated coeliac disease patients: a large cross-sectional study. BMC Gastroenterol. 2013;13:75.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Gujral N, Suh JW, Sunwoo HH. Effect of anti-gliadin IgY antibody on epithelial intestinal integrity and inflammatory response induced by gliadin. BMC Immunol. 2015;16:41–52.CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–381.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Dory A. Sample
    • 1
    • 2
  • Hoon H. Sunwoo
    • 1
    Email author
  • Hien Q. Huynh
    • 3
  • Heather L. Rylance
    • 4
  • Cheri L. Robert
    • 4
  • Bi-Wen Xu
    • 1
  • Sung H. Kang
    • 4
  • Naiyana Gujral
    • 1
  • Levinus A. Dieleman
    • 5
  1. 1.Faculty of Pharmacy and Pharmaceutical SciencesUniversity of AlbertaEdmontonCanada
  2. 2.Women and Children’s Health Research InstituteUniversity of AlbertaEdmontonCanada
  3. 3.Division of Pediatric GI Nutrition, Faculty of MedicineUniversity of AlbertaEdmontonCanada
  4. 4.Women and Children’s Health Research InstituteUniversity of AlbertaEdmontonCanada
  5. 5.Division of Gastroenterology, Faculty of MedicineUniversity of AlbertaEdmontonCanada

Personalised recommendations