Status:
COMPLETED
Autoimmune Diseases And Serum Anti-Nuclear Antibodies Positivity In Non-Celiac Wheat Sensitivity Patients
Lead Sponsor:
University of Palermo
Conditions:
Non-Celiac Wheat Sensitivity
Eligibility:
All Genders
18-70 years
Brief Summary
Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat, barley, and rye) that primarily affects the small intestine in genetically predisposed patients and resolv...
Detailed Description
Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat, barley, and rye) that primarily affects the small intestine in genetically predisposed patients and resolv...
Eligibility Criteria
Inclusion
- To diagnose NCWS the recently proposed criteria were adopted. All the patients met the following criteria
- negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) IgA and IgG antibodies
- absence of intestinal villous atrophy
- negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection)
- resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms
- symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As we previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges were performed too.
- Additional inclusion criteria were:
- age \>18 years
- follow-up duration longer than six months after the initial diagnosis
- at least two outpatient visits during the follow-up period.
Exclusion
- positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa
- self-exclusion of wheat from the diet and refusal to reintroduce it, before entering the study
- other "organic" gastrointestinal disorders
- nervous system disease and/or major psychiatric disorder
- physical impairment limiting physical activity
- menopause
- steroid and sex steroid therapy, hormone replacement therapy or ovariectomy.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02248545
Start Date
July 1 2011
End Date
June 1 2014
Last Update
September 25 2014
Active Locations (3)
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1
Internal Medicine Department of the Hospital of Sciacca (Agrigento)
Sciacca, Agrigento, Italy, 92019
2
Gastroenterology Unit of the "Civico" Hospital of Palermo
Palermo, Palermo, Italy, 90100
3
Internal Medicine Department of the University Hospital of Palermo
Palermo, Palermo, Italy, 90127