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107 / 108

Fasano, 2005;

No; analysis is ongoing

33 of 46 adults completed study

Not reported

0, 10 or 50 mg gluten/day

3 months

Intestinal biopsy, symptoms

Not reported

Abstract: Catassi et al., 2005b

Catassi et al., 1993

Yes

20 children (10 each dose level)

Commercial crude gliadin

100 mg or 500 mg gliadin/day

4 weeks

Intestinal biopsy, symptoms

Yes

Ciclitera et al., 1984

Yes

1 adult

White flour milled from Kolibri strain of wheat

10, 600, and 1000 mg gliadin

Intraduodenal infusion over 2 hr period; 3 doses on separate days

Intestinal biopsy

Yes

Ciclitera et al., 1984

Yes

3 adults

White flour milled from Kolibri strain of wheat

1000 mg of 4 gliadin subfractions

Intraduodenal infusion each subfraction at variable intervals of 3 to 11 days

Intestinal biopsy, symptoms

Yes

Ciclitera et al., 1985

Yes

10 adults

Not reported; article states that gluten-free bread usually contains 0.2 to 0.4 mg gliadin/30-g slice

6 slices/day Juvela gluten-free bread; oral

6 weeks

Intestinal biopsy,symptoms

Yes

Diagnostic

Individual

Assessment

Response

(Biomarker)

Data?

Duration

Montgomery et al, 1988

Yes

Dose Level(s)

12 adults on strict gluten- free diet and

13 adults on low-gluten diet

Not reported

Appendix 5: Evaluation of Gluten Oral Challenge Studies.

Gluten-free diet

Low-gluten diet (2.5 to 5 gm gluten/day)

Gluten-free diet: 6 to 27 months (mean 13 months);

Low-gluten diet: 3 to 14 months

Study

Intestinal biopsy, symptoms, anti- gluten Ab

Yes, graphs

Test Material

Published

Test Population

Revised Threshold Report

Page 107 of 108

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