Clinical trial NCT02344758: Gluten-free Diet Monitoring in Urine
Official title: Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Celiac Disease
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Instituto Hispalense de Pediatría
name: Hospitales Universitarios Virgen del Rocío
First posted: 2015-01-26
Enrollment: 134
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

Eligibility criteria: 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

Primary outcomes:
measure: Usual gluten-containing diet for healthy individuals
timeFrame: 1 month
Secondary outcomes:
measure: Usual gluten-free diet for celiac patients (home diet not modified for this trial)
timeFrame: 1 month
Other outcomes:
measure: Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten
timeFrame: 3 days
Locations:
city: Seville
country: Spain
facility: Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
Study officials:
affiliation: Department of Microbiology and Parasitology, University of Sevilla, Spain
name: Mª de Lourdes Moreno Amador, Dr
role: STUDY_CHAIR
affiliation: Biomedal S.L.
name: Ángel Cebolla Ramírez, Dr
role: STUDY_CHAIR
affiliation: Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain
name: Ángeles Pizarro Moreno, Dr
role: STUDY_CHAIR
affiliation: Biomedal, S.L., Sevilla, Spain
name: Alba Muñoz Suano, Dr
role: STUDY_CHAIR
affiliation: Department of Microbiology and Parasitology, University of Sevilla, Spain
name: Isabel Comino Montilla, Dr
role: STUDY_CHAIR
affiliation: Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría. Sevilla, Spain
name: Alfonso Rodríguez Herrera, Dr
role: STUDY_CHAIR
affiliation: Celimmune, Bethesda, MD, USA
name: Francisco León, Dr
role: STUDY_CHAIR
affiliation: Biomedal, S.L., Sevilla, Spain
name: Carolina Carrillo Carrión
role: STUDY_CHAIR
affiliation: Department of Microbiology and Parasitology, University of Sevilla, Spain
name: Carolina Sousa Martín, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.