Observational Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 21, 2019; 25(11): 1409-1420
Published online Mar 21, 2019. doi: 10.3748/wjg.v25.i11.1409
Gluten immunogenic peptide excretion detects dietary transgressions in treated celiac disease patients
Ana Florencia Costa, Emilia Sugai, María de la Paz Temprano, Sonia Isabel Niveloni, Horacio Vázquez, María Laura Moreno, M. Remedios Domínguez-Flores, Alba Muñoz-Suano, Edgardo Smecuol, Juan Pablo Stefanolo, Andrea F González, Angel Cebolla-Ramirez, Eduardo Mauriño, Elena F Verdú, Julio César Bai
Ana Florencia Costa, Emilia Sugai, María de la Paz Temprano, Sonia Isabel Niveloni, Horacio Vázquez, María Laura Moreno, Edgardo Smecuol, Juan Pablo Stefanolo, Andrea F González, Eduardo Mauriño, Julio César Bai: Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital, Buenos Aires 1263, Argentina
M. Remedios Domínguez-Flores, Alba Muñoz-Suano, Angel Cebolla-Ramirez, Department of Immunology, Biomedal S.L., Sevilla 41092, Spain
Elena F Verdú, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S4L8, Canada
Julio César Bai, Research Institutes, Universidad del Salvador, Buenos Aires 1050, Argentina
Author contributions: Costa AF contributed with patient enrolment and analysis of data; Sugai E performed biochemical tests, data analysis and interpretation; Temprano MdlP contributed to patient enrolment, dietary reports and assessment of compliance; Niveloni SI contributed to study design and patient enrolment; Vázquez H contributed to statistical analysis and data interpretation; Moreno ML contributed to patient enrolment and data analysis. Domínguez-Flores MR contributed with reagents; Muñoz-Suano A contributed with reagents; Smecuol E contributed to the study design and patient enrolment; Stefanolo JP contributed to data analysis; Gónzalez A contributed to dietary reports and assessment of compliance; Cebolla-Ramirez A contributed to study design and development of GIP tests; Mauriño E contributed to study design and critical review of the manuscript; Verdú EF contributed to language editing and critical revision of the manuscript for intellectual content; Bai JC contributed to study concept and design, analysis and interpretation of data, study direction and manuscript writing; All authors read and approved the final manuscript.
Institutional review board statement: The study was approved by Local Institutional Review Committees for Research and Ethics.
Informed consent statement: All patients signed a written informed consent approved by the Local Ethics Committee.
Conflict-of-interest statement: Authors from Biomedal S.L. did not participate in the study design, data analysis and writing of the manuscript. The remaining authors have no conflicts to disclose.
STROBE statement: The authors have read and checked the STROBE checklist.
Open-Access: This is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Julio César Bai, MD, Professor Emeritus, Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, Buenos Aires 1264, Argentina. jbai@intramed.net
Telephone: +54-11-43041018 Fax: +54-11-43041018
Received: December 14, 2018
Peer-review started: December 14, 2018
First decision: December 28, 2018
Revised: January 8, 2018
Accepted: January 14, 2019
Article in press: January 14, 2019
Published online: March 21, 2019
Abstract
BACKGROUND

Life-long removal of gluten from the diet is currently the only way to manage celiac disease (CeD). Until now, no objective test has proven useful to objectively detect ingested gluten in clinical practice. Recently, tests that determine consumption of gluten by assessing excretion of gluten immunogenic peptides (GIP) in stool and urine have been developed. Their utility, in comparison with conventional dietary and analytical follow-up strategies, has not been fully established.

AIM

To assess the performance of enzyme-linked immunosorbent assay (ELISA) and point-of-care tests (PoCTs) for GIP excretion in CeD patients on gluten-free diet (GFD).

METHODS

We conducted an observational, prospective, cross-sectional study in patients following a GFD for at least two years. Using the Gastrointestinal Symptom Rating Scale questionnaire, patients were classified at enrollment as asymptomatic or symptomatic. Gluten consumption was assessed twice by 3-d dietary recall and GIP excretion (by ELISA in stool and PoCTs (commercial kits for stool and urine) in two consecutive samples. These samples and dietary reports were obtained 10 day apart one from the other. Patients were encouraged to follow their usual GFD during the study period.

RESULTS

Forty-four patients were enrolled, of which 19 (43.2%) were symptomatic despite being on a GFD. Overall, 83 sets of stool and/or urine samples were collected. Eleven out of 44 patients (25.0%) had at least one positive GIP test. The occurrence of at least one positive test was 32% in asymptomatic patients compared with 15.8% in symptomatic patients. GIP was concordant with dietary reports in 65.9% of cases (Cohen´s kappa: 0.317). PoCT detected dietary indiscretions. Both ELISA and PoCT in stool were concordant (concomitantly positive or negative) in 67 out of 74 (90.5%) samples. Excretion of GIP was detected in 7 (8.4%) stool and/or urine samples from patients considered to be strictly compliant with the GFD by dietary reports.

CONCLUSION

GIP detects dietary transgressions in patients on long-term GFD, irrespective of the presence of symptoms. PoCT for GIP detection constitutes a simple home-based method for self-assessment of dietary indiscretions.

Keywords: Celiac disease, Follow-up, Gluten-free diet, Gluten immunogenic peptide excretion, Rapid tests

Core tip: Excreted gluten immunogenic peptides (GIPs) in stool and urine are specific indicators of gluten consumption in patients with celiac disease.GIP tests detect dietary indiscretions in treated celiac patients, irrespective of the presence of symptoms. GIPs were detected in stool and/or urine samples of patients considered to be strictly compliant with the gluten-free diet according to dietary reports. Point-of-care tests for GIP detection constitute simple home-based methods for self-assessment of dietary indiscretions.