Gut Permeability Assessment in Celiac and Gluten Sensitive Children

NCT02690532 | Completed

• 1 other identifier: 15-006018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Gut Permeability

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

  Baseline

Study Arms (3)

High risk group

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

Non-celiac group

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

Control Group

Healthy control group (matched for age and gender).

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of three groups of children, aged 2-17 years. The first group will be children with siblings that have celiac disease, the second group will be children with non-celiac gluten sensitivity and the third group will be healthy children.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Celiac Disease; Hypersensitivity; Gastrointestinal Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases

Study Officials

• Imad Absah, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)