Status:
COMPLETED
Diagnostic Significance of Positive EmA Antibodies in the Duodenal Culture Medium of Not-Celiac Wheat Sensitivity (NCWS)
Lead Sponsor:
University of Palermo
Conditions:
Not-celiac Gluten Sensitivity
Eligibility:
All Genders
18-65 years
Brief Summary
The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e. celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides celiac disease and whea...
Detailed Description
Gluten is the most important protein component of some grains, notably wheat, rye, and barley, which are the basis for a variety of wheat-derived alimentary products consumed throughout the world (bre...
Eligibility Criteria
Inclusion
- Adult patients, both genders, with age between 18-65 years, that has been previously diagnosed as NCWS, according to a DBPC method
- Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative)
- Patients showed positive EmAs in the culture medium of the duodenal biopsies
Exclusion
- Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above)
- Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)
- Subjects with Type 1 Diabetes
- Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
- Subjects with Helicobacter pylori infection and other gastrointestinal infection
- Pregnancy
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02203201
Start Date
January 1 2014
End Date
June 1 2020
Last Update
October 8 2020
Active Locations (2)
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1
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, Italy, 92019
2
Department of Internal Medicine, University Hospital of Palermo
Palermo, Italy, 90129