Gluten-free Diet Monitoring in Urine
- Conditions
- Celiac Disease
- Interventions
- Device: Non-invasive lateral flow test for monitoring gluten intakeBehavioral: gluten-free diet (GFD)Behavioral: gluten-containing diet
- Registration Number
- NCT02344758
- Lead Sponsor
- University of Seville
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- Celiac patient: childs (< 16 years) and adults (> 16 years)
- written informed consent
- 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
- participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celiac adult 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 Healthy child 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. Celiac adult Non-invasive lateral flow test for monitoring gluten intake 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 Healthy adult Non-invasive lateral flow test for monitoring gluten intake 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. Celiac child Non-invasive lateral flow test for monitoring gluten intake 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 Healthy child Non-invasive lateral flow test for monitoring gluten intake 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. Healthy adult 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. Celiac child 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
- Primary Outcome Measures
Name Time Method Usual gluten-containing diet for healthy individuals 1 month
- Secondary Outcome Measures
Name Time Method Usual gluten-free diet for celiac patients (home diet not modified for this trial) 1 month
Trial Locations
- Locations (1)
Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
🇪🇸Seville, Spain