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Completed

NCT Number: NCT02690532

Gut Permeability Assessment in Celiac and Gluten Sensitive Children

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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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Hypersensitivity Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gut Permeability

    Time frame: Baseline

    Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2016
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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