Gluten-free Diet Monitoring in Urine

Study Overview
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Brief Summary
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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
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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).

Official Title
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Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine

Conditions
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Celiac Disease

Intervention / Treatment
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* Device: Non-invasive lateral flow test for monitoring gluten intake
* Behavioral: gluten-free diet (GFD)
* Behavioral: gluten-containing diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Celiac patient: childs (< 16 years) and adults (> 16 years) written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celiac adult<br>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<br> <br> Behavioral: gluten-free diet (GFD)<br> <br> |
| Experimental: Celiac child<br>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<br> <br> Behavioral: gluten-free diet (GFD)<br> <br> |
| Active Comparator: Healthy adult<br>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<br> <br> Behavioral: gluten-containing diet<br> <br> |
| Active Comparator: Healthy child<br>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<br> <br> Behavioral: gluten-containing diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usual gluten-containing diet for healthy individuals |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usual gluten-free diet for celiac patients (home diet not modified for this trial) |  | 1 month |