Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
Non-celiac Wheat Sensitivity
About this trial
This is an interventional other trial for Non-celiac Wheat Sensitivity focused on measuring Non-celiac Wheat Sensitivity, fibromyalgia, synovitis
Eligibility Criteria
Inclusion Criteria:
All the patients met the recently proposed criteria:
- negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig) A and IgG antibodies
- absence of intestinal villous atrophy
- IgE-mediated immunoallergic tests negative to wheat and cow's milk protein (skin prick tests and/or serum specific IgE detection).
Adjunctive criteria adopted in our patients were:
- resolution of the gastrointestinal and extra-intestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms
- symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge, performed as described previously. DBPC cow's milk protein challenge will be also performed to diagnose cow's milk protein allergy.
Exclusion Criteria:
Exclusion criteria will be:
- age <18 years
- positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal
- self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
- other organic gastrointestinal diseases
- previously diagnosed rheumatic diseases
- nervous system disease and/or major psychiatric disorder
- physical impairment limiting physical activity
- menopause; steroid and sex steroid therapy, hormone replacement therapy or ovariectomy.
Sites / Locations
- Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
- Department of Internal Medicine, University Hospital of Palermo
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
No Intervention
No Intervention
NCWS patients
CD patients
IBS patients
Fifty consecutive adult patients with an irritable bowel syndrome (IBS)-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients will be recruited between January 2017 and January 2018 at 2 centers: the Department of Internal Medicine at the University Hospital of Palermo, Italy, and the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy. All subjects will undergo clinical evaluation and hands and feet joints ultrasonography at the Rheumatology Unit of the University of Palermo, Italy.
Fifty sex- and age-matched subjects with CD, diagnosed according to standard criteria during the same study period and enrolled, at the same 2 centers, as first control group. All subjects will undergo clinical evaluation and hands and feet joints ultrasonography at the Rheumatology Unit of the University of Palermo, Italy.
Fifty sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled, at the same 2 centers, as second control group. All subjects will undergo clinical evaluation and hands and feet joints ultrasonography at the Rheumatology Unit of the University of Palermo.