title: AGY, a Novel Egg Yolk-Derived Anti-gliadin Antibody, Is Safe for Patients with Celiac Disease.
abstract: 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.
authors.affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-142H Katz Centre for Pharmacy and Health Research, 11361-87 Ave, Edmonton, AB, T6G 2E1, Canada.|Women and Children's Health Research Institute, University of Alberta, 4-501 Edmonton Clinic Health Academy, 11405-87 Ave, Edmonton, AB, T6G 1C9, Canada.
authors.forename: Dory A
authors.initials: DA
authors.lastname: Sample
authors.affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-142H Katz Centre for Pharmacy and Health Research, 11361-87 Ave, Edmonton, AB, T6G 2E1, Canada. hsunwoo@ualberta.ca.
authors.forename: Hoon H
authors.initials: HH
authors.lastname: Sunwoo
authors.affiliation: Division of Pediatric GI Nutrition, Faculty of Medicine, University of Alberta, 4-579 Edmonton Clinic Health Academy, 11405-87 Ave, Edmonton, AB, T6G 1C9, Canada.
authors.forename: Hien Q
authors.initials: HQ
authors.lastname: Huynh
authors.affiliation: Women and Children's Health Research Institute, University of Alberta, 4-081 Edmonton Clinic Health Academy, 11405-87 Ave, Edmonton, AB, T6G 1C9, Canada.
authors.forename: Heather L
authors.initials: HL
authors.lastname: Rylance
authors.affiliation: Women and Children's Health Research Institute, University of Alberta, 4-081 Edmonton Clinic Health Academy, 11405-87 Ave, Edmonton, AB, T6G 1C9, Canada.
authors.forename: Cheri L
authors.initials: CL
authors.lastname: Robert
authors.affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-142H Katz Centre for Pharmacy and Health Research, 11361-87 Ave, Edmonton, AB, T6G 2E1, Canada.
authors.forename: Bi-Wen
authors.initials: BW
authors.lastname: Xu
authors.affiliation: Women and Children's Health Research Institute, University of Alberta, 4-081 Edmonton Clinic Health Academy, 11405-87 Ave, Edmonton, AB, T6G 1C9, Canada.
authors.forename: Sung H
authors.initials: SH
authors.lastname: Kang
authors.affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-142H Katz Centre for Pharmacy and Health Research, 11361-87 Ave, Edmonton, AB, T6G 2E1, Canada.
authors.forename: Naiyana
authors.initials: N
authors.lastname: Gujral
authors.affiliation: Division of Gastroenterology, Faculty of Medicine, University of Alberta, Zeidler Bld 2-24, 130 University Campus, Edmonton, AB, T6G 2X8, Canada.
authors.forename: Levinus A
authors.initials: LA
authors.lastname: Dieleman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000627:therapeutic use*; D002446:Celiac Disease / Q000188:drug therapy*; D004530:Egg Yolk / Q000737:chemistry*; D005260:Female; D005903:Gliadin / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D000637:Transaminases / Q000276:immunology; D055815:Young Adult
chemical_list: D000906:Antibodies; D005903:Gliadin; D000637:Transaminases
keywords: AGY; Anti-gliadin antibody; Celiac disease; Gluten-free diet