Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 7 of 13 for:    gluten | Open Studies | United States

Gut Permeability Assessment in Celiac and Gluten Sensitive Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Mayo Clinic
Information provided by (Responsible Party):
Imad Absah, Mayo Clinic Identifier:
First received: February 19, 2016
Last updated: May 26, 2016
Last verified: May 2016
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.

Celiac Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Gut Permeability [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity

Estimated Enrollment: 60
Study Start Date: March 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
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).

Detailed 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.

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02690532

Contact: James Allen 507-255-9899

United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Imad Absah, MD         
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Imad Absah, MD Mayo Clinic
  More Information

Responsible Party: Imad Absah, M.D., Assistant Professor of Pediatrics, Mayo Clinic Identifier: NCT02690532     History of Changes
Other Study ID Numbers: 15-006018 
Study First Received: February 19, 2016
Last Updated: May 26, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
Non-celiac gluten intolerance
Gastrointestinal Diseases
Digestive System Diseases

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases processed this record on October 21, 2016