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Journal Review

Journal Review. Leah Wendland December 3rd 2012. Prospective Study of Clinical and Histological Safety of Pure and Uncontaminated Canadian Oats in the Management of Celiac Disease. Michael Sai Lai Sey,MD: Jeremy Parfitt,MD,FRCPC: Jamie Gregor,MD,FRCPC. Objectives. Background Objective

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Journal Review

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  1. Journal Review Leah Wendland December 3rd 2012

  2. Prospective Study of Clinical and Histological Safety of Pure and Uncontaminated Canadian Oats in the Management of Celiac Disease Michael Sai Lai Sey,MD: Jeremy Parfitt,MD,FRCPC: Jamie Gregor,MD,FRCPC

  3. Objectives • Background • Objective • Methodology • Results • Conclusion • Critique

  4. Celiac Disease and Oats • Cross-contamination was a major reason why oats were considered unsafe in the past • Oats, wheat and barley are usually grown next to each other, processed in the same area, milled with the same equipment, and transported using the same containers

  5. Objective • To assess the safety of oats manufactured under the guidelines developed by the Canadian Celiac Association for individuals with celiac disease

  6. Guidelines Table 1. Canadian Celiac Association Guidelines for the Production of Pure Oats Seed purity: Foundation #1 Canada Seed Act (≤1 wheat, barley, or rye seed per kg of oat groat) Production: Dedicated fields, harvesting, processing, storage, and transportation equipment strictly for oats Confirmation: Purity confirmed by R5 enzyme-linked immunosorbent assay, which is able to detect ≥3 parts per million (ppm) gluten contamination (gluten-free diet ≤20 ppm)

  7. Methodology 19 celiac patients considered • Asymptomatic • GFD 1 year • Normal tTG  4 patients declined  11 patients study entry Mod-Marsh Score ≤ 1 10 patients compliant with GFD    PER-PROTOCOL ANALYSIS 15 patients enrolled INTENTION-TO-TREAT ANALYSIS

  8. Methodology • 15 participants (Intention to Treat) • Criteria • Asymptomatic on GF diet for at least a year • Biopsy to confirm normal tissue Transglutaminase (tTG) levels • Exclusion • Uncertain diagnosis of celiac disease (other causes of villous atrophy) • GFD non compliance, not in remission

  9. Methodology • Process • Consume 350g pure uncontaminated oats per week for 12 weeks • Tested for gluten content using R5 enzyme-linked immunosorbent assasy (ELISA) • Premeasured bags of 12 (350g each) • Donated by Cream Hill Estates • Record what was eaten 2 random times in 6 weeks • Follow up at week 0, 6 and 12 • Assessed symptoms and serum tests • Continue GF diet • Biopsies obtained at week 0 and week 12

  10. Biopsies • Esophogastroduodenoscopy (EGD) was conducted on each participant • Biopsies were obtained at week 0 and week 12 • Taken from second part of the duodenum • Reviewed and scored by Dr. Parfitt using the Modified Marsh-Oberhuber classification

  11. Modified Marsh Score Table 2. Modified Marsh–Oberhuber Classification Score IEL Crypts Villi 0 <40 Normal Normal 1 >40 Normal Normal 2 >40 Hypertrophic Normal 3a >40 Hypertrophic Mild atrophy 3b >40 Hypertrophic Marked atrophy 3c >40 Hypertrophic Absent *IEL, intraepithelial lymphocytes, expressed as number of IEL/100 epithelial cells.

  12. Results • No symptomatic recurrences • No serological relapses in ITT or PP • 2 cases of histological deterioration in ITT • 1 did not follow GF diet • 1 progressed from Marsh 3a to 3b

  13. Conclusion • Supports safety of oats manufactured under the Canadian Celiac Association guidelines for individuals with Celiac Disease • More studies need to be done to confirm this study due to the small sample size and the non-randomization, and un-blind study

  14. Critique • Limitations • Small sample size • No comparison group • Not blind • Unclear how participants were recruited • Self reporting diaries • Positive • Provided biopsies at the beginning and end • Did not have participants consume oats in excess • Used Celiac Disease Standard scoring for biopsies

  15. Thank You! Questions?

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