Overview of clinical studies evaluating performance of iVYCHECK for Gluten detection in stool and urine samples
Urine and Stool Gluten: CELIM-NRCD-001 (Finland)
- Celimmune’s prospective, blinded, randomized, placebo-controlled, study of AMG 714 (anti-IL-15 monoclonal antibody) in a gluten challenge study with 63 subjects. Six measures over the course of 20 weeks. Correlation with most celiac endpoints: Intestinal histology, serology, symptoms.
Urine and Stool Gluten: CELIM-RCD-002 (US, France, Holland, Spain, Finland)
- Celimmune’s prospective, blinded, randomized, placebo-controlled, study of AMG 714 in Refractory celiac Disease Type II, an in situ small bowell T cell lymphoma. 24 subjects in 5 countries. Same measures as NRCD-001 plus flow cytometry, QoL (quality of life).
Urine and Stool Gluten (Rijnstate Hospital, The Netherlands)
- Prospective, blinded, randomized, placebo-controlled, cross-over gluten challenge study of patients on a gluten-free diet who experience chronic intermittent intestinal complaints. Serology, PRO questionnaires, Quality of Life. ~100 subjects .
Stool Gluten: CADER 02/2012 study (Spain)
- Assessment of influence of detection of gluten in in stool on the persistence of villous atrophy 2 years after initiating a GFD (diet non-responsive celiac disease and refractory celiac disease).
- Prospective and multicenter study comparing pediatric and adult populations.
Stool Gluten: Hospital Bonorino Udaondo study (Argentina)
- Establish the relationship between gluten intake and the persistence of symptoms in celiac patients following a GFD for more than 2 years.
- Includes quality of life and role of FODMAPs (fermentable oligo-, di-, monosaccharides and polyol)
Stool Gluten: Jefferson University study (US)
- ~20 subjects with celiac and ~60 with Non-Celiac Gluten Sensitivity