An Early Phase 1 interventional study of Non-invasive lateral flow test for monitoring gluten intake and gluten-free diet (GFD) in Celiac Disease, sponsored by University of Seville. Completed at 1 site in Spain. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by University of Seville · Early Phase 1 and Interventional
The purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.
To date, the mainstay of the management of CD is a strict life-long adherence to gluten-free diet (GFD). Follow-up monitoring of the improvement of patients on GFD is essential to assess symptomatic recovery and to monitor complications, as well as to assist patients with dietary compliance. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.
In this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (GIP) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-GIP moAb immunochromatographic strips (IC-strips).
332 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's enrollment of 134 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →University of Seville is the lead sponsor of 127 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient \>16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for \>2 years
Device: Non-invasive lateral flow test for monitoring gluten intake · Behavioral: gluten-free diet (GFD)
Patient \<16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for \>2 years
Device: Non-invasive lateral flow test for monitoring gluten intake · Behavioral: gluten-free diet (GFD)
Healthy individual \> 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study.
Device: Non-invasive lateral flow test for monitoring gluten intake · Behavioral: gluten-containing diet
Healthy individual \< 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study.
Device: Non-invasive lateral flow test for monitoring gluten intake · Behavioral: gluten-containing diet
Usual gluten-containing diet for healthy individuals
Time frame: 1 month
Usual gluten-free diet for celiac patients (home diet not modified for this trial)
Time frame: 1 month
Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten
Time frame: 3 days
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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University of Seville