Gut Permeability Assessment in Celiac and Gluten Sensitive Children

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Mayo Clinic

Status

Completed

Conditions

Celiac Disease

Study type

Observational

Funder types

Other

Identifiers

NCT02690532
15-006018

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 3 patient groups

High risk group
Description:
Children who are at high risk for developing celiac disease (siblings diagnosed with celiac disease).
Non-celiac group
Description:
Children who are self-diagnosed with non-celiac gluten sensitivity.
Control Group
Description:
Healthy control group (matched for age and gender).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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