Gluten-free Diet Monitoring in Urine

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344758
• Other study ID #: CELIFLUID1
• Status: Completed
• Phase: Phase 0
• First received: January 14, 2015
• Last updated: January 22, 2015
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Device:
• Non-invasive lateral flow test for monitoring gluten intake

Behavioral:
• gluten-free diet (GFD)

• gluten-containing diet

Locations

Country	Name	City	State
Spain	Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville	Seville

Sponsors (3)

Lead Sponsor	Collaborator
University of Seville	Hospitales Universitarios Virgen del Rocío, Instituto Hispalense de Pediatría

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

Comino I, Real A, Vivas S, Síglez MÁ, Caminero A, Nistal E, Casqueiro J, Rodríguez-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. — View 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. — View Citation

Morón B, Bethune MT, Comino I, Manyani H, Ferragud M, López 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. — View Citation

Morón B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megías M, Thomas Mdel C, López 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. — View Citation

Real A, Comino I, Moreno Mde L, López-Casado MÁ, Lorite P, Torres MI, Cebolla Á, 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. — View Citation

Shan L, Molberg Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten		3 days	Yes
Primary	Usual gluten-containing diet for healthy individuals		1 month	Yes
Secondary	Usual gluten-free diet for celiac patients (home diet not modified for this trial)		1 month	Yes