Gluten-free Diet Monitoring in Urine

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02344758

Enrollment

134

Registered

2015-01-26

Start date

2013-04-30

Completion date

2013-12-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

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).

Interventions

DEVICENon-invasive lateral flow test for monitoring gluten intake

BEHAVIORALgluten-free diet (GFD)

BEHAVIORALgluten-containing diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Usual gluten-containing diet for healthy individuals	1 month

Secondary

Measure	Time frame
Usual gluten-free diet for celiac patients (home diet not modified for this trial)	1 month

Other

Measure	Time frame
Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten	3 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026