Status:
COMPLETED
Gluten Sensitivity in Non-Celiac Patients
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Gluten Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The idea is to evaluate if the so called "Gluten Sensitivity" is a real clinical entity. Gluten sensitive (GS) persons are defined as those patients, being neither celiac or allergic to weat, who deve...
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 flour and wheat derived alimentary products consumed throughout the ...
Eligibility Criteria
Inclusion
- Adult patients with age between 18-65 with signs/symptoms compatible with gluten-triggered disorders
- Patients testing negative for celiac disease either by biopsy Marsh 0-1 or those who are HLA-DQ2 and DQ8 negative, as well as tTG and EMA negative
- Patients that improved on a gluten free diet
Exclusion
- Subjects diagnosed with celiac disease (positive TTG and/or EMA, and histology positive with Marsh II or above);
- Subjects diagnosed with wheat allergy
- Subjects with Type 1 Diabetes (T1D)
- Subjects with Inflammatory Bowel Disease (ulcerative colitis or Crohn's disease)
- Pregnancy
- Subjects with Helicobacter Pylori infection and other gastrointestinal infection
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01485341
Start Date
June 1 2011
End Date
April 1 2016
Last Update
April 13 2016
Active Locations (7)
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1
Center for Celiac Research & Treatment, Yawkey Center for Outpatients Care
Boston, Massachusetts, United States, 02114
2
Università Politecnica delle Marche
Ancona, Italy
3
Gastroenterologia ed Endoscopia digestiva, Ospedale San Giuseppe Moscati
Avellino, Italy
4
Gastroenterology, Second University of Naples
Naples, Italy, 80138