Status:
COMPLETED
Anemia in Non-celiac Wheat Sensitivity
Lead Sponsor:
University of Palermo
Conditions:
Non-celiac Gluten Sensitivity
Anemia
Eligibility:
All Genders
18-65 years
Brief Summary
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). This is very often a self-rep...
Detailed Description
In recent years, a new gluten- or wheat-related disease has emerged, a condition labelled "non-celiac gluten sensitivity" (NCGS) or "non-celiac wheat sensitivity" (NCWS). This is very often a self-rep...
Eligibility Criteria
Inclusion
- To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:
- \- negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A 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 the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too.
- To diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:
- \- positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies presence of intestinal villous atrophy.
- To diagnose IBS the standard Rome II (for retrospective patients) and Rome III (for prospective patients) Criteria will be adopted. None of these subjects improved on an elimination diet without wheat, cow's milk, egg, tomato, or chocolate.
Exclusion
- For NCWS diagnosis it will be evaluated the following exclusion criteria:
- \- 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 previously diagnosed gastrointestinal disorders, other previously diagnosed gynaecological disorders, nervous system disease and/or major psychiatric disorder, physical impairment limiting physical activity.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04377061
Start Date
January 1 2020
End Date
January 1 2022
Last Update
February 7 2022
Active Locations (3)
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1
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, Italy, 92019
2
Internal Medicine Division of the "Cervello-Villa Sofia" Hospital
Palermo, PA, Italy, 90129
3
Department of Internal Medicine, University Hospital of Palermo
Palermo, Italy, 90129