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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

Abstract

Background

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.

Aims

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

Methods

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.

Results

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.

Conclusion

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.

Keywords

Anti-gliadin antibody Celiac disease Gluten-free diet AGY 

Notes

Acknowledgments

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.

Funding

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

Compliance with ethical standards

Conflict of interest

None.

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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

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