A Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease
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|ClinicalTrials.gov Identifier: NCT03521180|
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : February 26, 2020
This is a model development, open label, no therapeutic treatment, three sequential group, short term-gluten challenge study in subjects with celiac disease. Immune responses are evaluated following gluten challenge.
Approximately fifteen subjects with celiac disease will be enrolled in up to three sequential groups (5 subjects per group).
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Model Development, Clinical Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease.|
|Actual Study Start Date :||May 11, 2018|
|Actual Primary Completion Date :||July 18, 2019|
|Actual Study Completion Date :||July 18, 2019|
Subjects with Celiac Disease
Group 1 will start the gluten challenge with 4 slices of white bread once daily for 3 days. Blood will be taken at pre-specified time points for up to 9 days following the start of gluten challenge for biomarker analyses.
Based on data from the first 5 subjects, the 2nd group of 5 subjects may: 1) not be needed if the objectives are met; 2) receive gluten at increased quantity (not to exceed 6 slices of bread once daily for 3 days) or have biomarker samples collected at adjusted time points; 3) same as the first 5 subjects; 4) reducing the duration of gluten free diet for a minimum of 3 months instead of 6 month for the Inclusion Criteria # 5;5) subjects may be re-enrolled once.
The same applies to the 3rd group of subjects. A notification will be provided to the clinical study site for detailed changes.
- Gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC [ Time Frame: Approximately 10 days ]The number of gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC will be reported separately by flow cytometry .
- Evaluation of Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by Flow Cytometry [ Time Frame: Approximately 10 days ]Gliadin specific T cells will be evaluated by flow cytometry using fluorescently labelled HLA-gliadin tetramers that selectively bind to gliadin-specific T-cells.
- Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by ELISPOT [ Time Frame: approximately 10 days ]Gliadin specific T cells will be evaluated using Enzyme-linked immunospot (ELISPOT) which measure the number of cells secreting cytokine in response to gliadin binding.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521180
|United States, Texas|
|Dallas, Texas, United States, 75247|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Study Director:||Ying Ye, PhD||Celgene|