Gluten-free Diet Monitoring in Urine

NCT02344758 | Completed Early Phase 1 DMC

• 1 other identifier: CELIFLUID1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Usual gluten-containing diet for healthy individuals

  1 month

Secondary Outcomes (1)

• Usual gluten-free diet for celiac patients (home diet not modified for this trial)

  1 month

Other Outcomes (1)

• Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten

  3 days

Study Arms (4)

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

Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-free diet (GFD)

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

Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-free diet (GFD)

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.

Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-containing diet

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.

Device: Non-invasive lateral flow test for monitoring gluten intake; Behavioral: gluten-containing diet

Interventions

Non-invasive lateral flow test for monitoring gluten intake DEVICE

Celiac adult; Celiac child; Healthy adult; Healthy child

gluten-free diet (GFD) BEHAVIORAL

Celiac adult; Celiac child

gluten-containing diet BEHAVIORAL

Healthy adult; Healthy child

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Celiac patient: childs (\< 16 years) and adults (\> 16 years)
• written informed consent

You may not qualify if:

• presence of family history of CD
• digestive disease symptoms
• known medical disease
• 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

Sponsors & Collaborators

• University of Seville: lead
• Instituto Hispalense de Pediatría: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (1)

Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville

Seville, Seville, 41012, Spain

Location

Related Publications (8)

• 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.

  PMID: 18509534 BACKGROUND

• 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.

  PMID: 18258632 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.

  PMID: 12223360 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.

  PMID: 12351792 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.

  PMID: 22258271 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.

  PMID: 22886585 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.

  PMID: 24963630 BACKGROUND

• 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.

  PMID: 26608460 DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 26, 2015
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

ES (1)