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NCT02690532 Clinical Trial

Gut Permeability Assessment in Celiac and Gluten Sensitive Children

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02690532
Other study ID # 15-006018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2016
Est. completion date August 1, 2018

Study information
Verified date August 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

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