“WHEAT-SENSITIVITY EVALUATED BY DOUBLE-BLIND PLACEBO CONTROLLED METHOD: RISK FOR MALNUTRITION, OSTEOPOROSIS AND ASSOCIATED AUTOIMMUNE DISEASES”.

    Progetto: Research project

    Dettagli progetto

    Description

    Non-celiac wheat sensitivity (NCWS) is a new and very poorly defined clinical entity. Some Authors consider it as “a sister of CD”, some other as “psychosomatic” disorder with a market which addresses the patients towards a gluten-free diet. Very few prospective double-blind studies have been published on NCWS and conflicting data have been reported. Our hypotesis are: does NCWS exist and is it a condition similar to CD? Have NCWS patients the same or similar risks of CD patients? Is really need a strict gluten-free diet for NCWS patients? Are there mucosal immunological marker of NCWS? The aims of our study is to evaluate: the existence of NCWS estimated during a 3-years period in patients with IBS-like clinical presentation; the frequency of malnutrition, osteoporosis, autoimmune associated diseases and oral mucosa lesions in NCWS patients; to search for mucosal immunolocal markers of NCWS. The double-blind placebo-controlled (DBPC) challenge method will be used to pose NCWS diagnosis. As we demonstrated that about two third of NCWS suffered from cow’s milk protein (CMP) sensitivity also, a DBPC challenge with CMP will be also planned. Patients will be consequently divided in three groups: NCWS alone, NCWS plus CMP- (multiple foods-) sensitivity and IBS not due to NCWS. The following aspects will be evaluated: nutritional parameters, bone mineral density, frequency of positive serum antibodies and autoimmune diseases, assessment of oral soft and hard tissue lesions. Histology and Cytokines studies on duodenal mucosa samples will be performed at the entry in the study. Project's results will permit: to add data about the existence of NCWS; to give data about the frequency of malnutrition, osteoporosis, autoimmune associated diseases and oral mucosa lesions in NCWS patients; to find immunological markers of NCWS in the intestinal mucosa specimens.

    Layman's description

    BackgroundNon-celiac wheat sensitivity (NCWS) is a new and very poorly defined clinicalentity. Some Authors consider it as “ a sister of CD”, some other as“psychosomatic” disorder with a market which addresses the patients towards agluten-free diet. Very few prospective double-blind studies have been publishedon NCWS and conflicting data have been reported.HypothesisDoes NCWS exist and is it a condition similar to CD ?Have NCWS patients the same or similar risks of CD patients ?Is really need a strict gluten-free diet for NCWS patients ?Experimental designThe double-blind placebo-controlled (DBPC) challenge method will be used to pose NCWS diagnosis. As we demonstrated that about two third of NCWS sufferedfrom cow’s milk protein (CMP) sensitivity also, a DBPC challenge with CMP will be also planned. Patients will be consequently divided in three groups: NCWS alone,NCWS plus CMP- (multiple foods-) sensitivity and IBS not due to NCWS. The following aspects will be evaluated: nutritional parameters, bone mineraldensity, frequency of positive serum antibodies and autoimmune diseases, assessment of oral soft and hard tissue lesions.Histology and Cytokines studies on duodenal mucosa samples will be performed at the entry in the study.

    Key findings

    Salute
    StatoFinito
    Data di inizio/fine effettiva11/1/1410/31/17