Gluten-free Diet Monitoring in Urine

University of Seville

Status and phase: Completed; Early Phase 1

Conditions: Celiac Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02344758

CELIFLUID1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 134 patients

Sex: All

Ages: 3+ years old

Volunteers: No 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

Trial design

134 participants in 4 patient groups

Celiac adult

Experimental group

Description:

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

Treatment:

Behavioral: gluten-free diet (GFD)

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

Celiac child

Experimental group

Description:

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

Treatment:

Behavioral: gluten-free diet (GFD)

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

Healthy adult

Active Comparator group

Description:

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.

Treatment:

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

Behavioral: gluten-containing diet

Healthy child

Active Comparator group

Description:

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.

Treatment:

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

Behavioral: gluten-containing diet