Gut Permeability Assessment in Celiac and Gluten Sensitive Children

Completed

• Conditions: Celiac Disease

• Registration Number: NCT02690532
• Lead Sponsor: Mayo Clinic

Brief Summary

This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar \& water solution), and are hoping to prove its effectiveness in a clinical setting.

Detailed Description

The aim of this study is to assess effect of gluten on the gut barrier function in patients at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study will assess the gut permeability in three groups of patients 1) children who are at high risk for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender. Patients will undergo celiac serologic and genetic testing, after which the rhamnose test will be performed to assess the presence of increased gut permeability.

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Study Start: 2016-03
• Primary Completion: 2018-07-01
• Status Verified: 2018-08
• Study Completion: 2018-08-01
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut Permeability	Baseline	Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States