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| Name | Class |
|---|---|
| Instituto Hispalense de Pediatría | UNKNOWN |
| Hospitales Universitarios Virgen del Rocío | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celiac adult | Experimental | 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 |
|
| Celiac child | Experimental | 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 | Active Comparator | 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 child | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive lateral flow test for monitoring gluten intake | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usual gluten-containing diet for healthy individuals | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Usual gluten-free diet for celiac patients (home diet not modified for this trial) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten | 3 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mª de Lourdes Moreno Amador, Dr | Department of Microbiology and Parasitology, University of Sevilla, Spain | Study Chair |
| Ángel Cebolla Ramírez, Dr | Biomedal S.L. | Study Chair |
| Ángeles Pizarro Moreno, Dr | Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain | Study Chair |
| Alba Muñoz Suano, Dr | Biomedal, S.L., Sevilla, Spain | Study Chair |
| Isabel Comino Montilla, Dr | Department of Microbiology and Parasitology, University of Sevilla, Spain | Study Chair |
| Alfonso Rodríguez Herrera, Dr | Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría. Sevilla, Spain | Study Chair |
| Francisco León, Dr | Celimmune, Bethesda, MD, USA | Study Chair |
| Carolina Carrillo Carrión | Biomedal, S.L., Sevilla, Spain | Study Chair |
| Carolina Sousa Martín, Professor | Department of Microbiology and Parasitology, University of Sevilla, Spain |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville | Seville | Seville | 41012 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18509534 | Background | Moron B, Bethune MT, Comino I, Manyani H, Ferragud M, Lopez MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294. | |
| 18258632 | Background |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| gluten-free diet (GFD) | Behavioral |
|
| gluten-containing diet | Behavioral |
|
| Principal Investigator |
| Moron B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megias M, Thomas Mdel C, Lopez MC, Sousa C. Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide. Am J Clin Nutr. 2008 Feb;87(2):405-14. doi: 10.1093/ajcn/87.2.405. |
| 12223360 | Background | Hausch F, Shan L, Santiago NA, Gray GM, Khosla C. Intestinal digestive resistance of immunodominant gliadin peptides. Am J Physiol Gastrointest Liver Physiol. 2002 Oct;283(4):G996-G1003. doi: 10.1152/ajpgi.00136.2002. |
| 12351792 | Background | Shan L, Molberg O, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. doi: 10.1126/science.1074129. |
| 22258271 | Background | Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18. |
| 22886585 | Background | Comino I, Real A, Moreno Mde L, Montes R, Cebolla A, Sousa C. Immunological determination of gliadin 33-mer equivalent peptides in beers as a specific and practical analytical method to assess safety for celiac patients. J Sci Food Agric. 2013 Mar 15;93(4):933-43. doi: 10.1002/jsfa.5830. Epub 2012 Aug 6. |
| 24963630 | Background | Real A, Comino I, Moreno Mde L, Lopez-Casado MA, Lorite P, Torres MI, Cebolla A, Sousa C. Identification and in vitro reactivity of celiac immunoactive peptides in an apparent gluten-free beer. PLoS One. 2014 Jun 25;9(6):e100917. doi: 10.1371/journal.pone.0100917. eCollection 2014. |
| 26608460 | Derived | Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |