Clinical Trial Finder

Inclusion Criteria:

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. Additional inclusion criteria will be:

• - 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 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 "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.

Celiac disease (CD) has been reported to increase the risk of malnutrition due to malabsorption. More recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. That previous study also showed a percentage of NCWS patients had weight loss and anemia: whether these depended on the intestinal malabsorption or not remains unclear. As yet no data are available on the presence and prevalence of low bone mass density (BMD) in NCWS patients. The aims of the present study is 1) to investigate the prevalence of malnutrition in NCWS patient and 2) to search for a possible correlation with other clinical characteristics, in particular the body mass index (BMI), of NCWS patients.