Gluten-free Diet Monitoring in Urine

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

Interventions

DEVICE

Non-invasive lateral flow test for monitoring gluten intake

BEHAVIORAL

gluten-free diet (GFD)

BEHAVIORAL

gluten-containing diet

Sponsors & Collaborators

• Instituto Hispalense de Pediatría

  collaborator UNKNOWN

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• University of Seville

  lead OTHER

Principal Investigators

• Mª de Lourdes Moreno Amador, Dr · Department of Microbiology and Parasitology, University of Sevilla, Spain

• Ángel Cebolla Ramírez, Dr · Biomedal S.L.

• Ángeles Pizarro Moreno, Dr · Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain

• Alba Muñoz Suano, Dr · Biomedal, S.L., Sevilla, Spain

• Isabel Comino Montilla, Dr · Department of Microbiology and Parasitology, University of Sevilla, Spain

• Alfonso Rodríguez Herrera, Dr · Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría. Sevilla, Spain

• Francisco León, Dr · Celimmune, Bethesda, MD, USA

• Carolina Carrillo Carrión · Biomedal, S.L., Sevilla, Spain

• Carolina Sousa Martín, Professor · Department of Microbiology and Parasitology, University of Sevilla, Spain

Study Design

Allocation

RANDOMIZED

Model

PARALLEL

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2013-07-31

Completion

2013-12-31

Countries

• Spain

Study Locations