Gut Permeability Assessment in Celiac and Gluten Sensitive Children

The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02690532

Enrollment

Registered

2016-02-24

Start date

2016-03-31

Completion date

2018-08-01

Last updated

2018-08-15

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

Conditions

Celiac Disease

Keywords

Celiac, Gluten, Sensitivity, Permeability, Non-celiac gluten intolerance, Gastrointestinal Diseases, Digestive System Diseases

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

High Risk group: * Sibling with a confirmed diagnosis of celiac disease * No history Celiac disease or any other bowel disease Non-Celiac Gluten Sensitivity group: * Self-diagnosis of gluten sensitivity * No history of celiac disease or other bowel disease Healthy group: * Absence of celiac disease or any other bowel disease * No sensitivity to gluten

Design outcomes

Primary

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

Countries

United States

Outcome results