Gut Permeability Assessment in Celiac and Gluten Sensitive Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Celiac Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk group

Children who are at high risk for developing celiac disease (siblings diagnosed with celiac disease).

No interventions assigned to this group

Non-celiac group

Children who are self-diagnosed with non-celiac gluten sensitivity.

No interventions assigned to this group

Control Group

Healthy control group (matched for age and gender).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes