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NCWS
Sponsor study identifier
observational
50
1 country
2
Study Start
January 1, 2014
Actual (reported)Primary Completion
October 1, 2016
Actual (reported)Study Completion
June 1, 2020
Actual (reported)The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e. celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides celiac disease and wheat allergy, there are cases of gluten reactions in which neither autoimmune nor IgE-mediated allergic mechanisms are involved. These are generally defined as GS or Not-celiac wheat sensitivity (NCWS). Typically, NCWS diagnosis is made by exclusion, and an elimination diet and an "open challenge" (i.e., the monitored reintroduction of gluten-containing foods) are most often used to evaluate whether health improves or worsen with the elimination or reintroduction of gluten in the diet, respectively. In some circumstances, it is very difficult to distinguish between NCWS and celiac disease. The presence of positive celiac disease specific serum antibodies (anti-tissue transglutaminase (anti-tTG), and anti-endomysium (EmAs) antibodies) is of paramount importance to pose the diagnosis. However, it is well known that the frequency of a positive serology is dependent by the severity of the intestinal damage. Consequently, patients with less severe histology damage (Marsh 1) can have negative serum antibodies. Previous studies had demonstrated that EmAs are produced by the intestinal lymphocytes and previous data from our group showed that EmAs assay in the culture medium of the intestinal biopsies has higher diagnostic accuracy than serum EmAs in diagnosis. Therefore, the aims of our study are to evaluate the clinical-serologic-histology course of NCWS patients, showing positive EmAs assay in the culture medium of the duodenal biopsies at the time of the first evaluation, and the adherence to a gluten-free diet in NCWS patients after a previous full evaluation and a NCWS diagnosis based on double-blinded placebo-controlled (DBPC) challenge.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2014
Actual (reported)June 14, 2014
Actual (reported)July 29, 2014
Actual (reported)October 1, 2016
Actual (reported)June 1, 2020
Actual (reported)Changes in the intestinal histology of NCWS patients who tested positives for EmAs in the culture medium of the intestinal biopsies, at the time of the first evaluation.
Intestinal histology re-evaluation after at least one year since the initial NCWS diagnosis was posed. Marsh classification will be adopted: change from baseline (1st evaluation) to 2nd evaluation. The above parameter will be evaluated taking into account whether the patients adhered or not to a wheat-free diet.
At baseline and after at least one year since the initial NCWS diagnosis was posed.
Serum anti-tTG antibodies evaluation.
At baseline and after at least one year since the initial NCWS diagnosis was posed.
Serum DPG antibodies evaluation.
At baseline and after at least one year since the initial NCWS diagnosis was posed.
Serum AGA evaluation.
At baseline and after at least one year since the initial NCWS diagnosis was posed.
Adherence to a wheat-free diet
At baseline and after at least one year since the initial NCWS diagnosis was posed.
Symptoms/signs evaluation.
At baseline and after at least one year since the initial NCWS diagnosis was posed.
NCWS patients who had showed a negative celiac disease serology and a Marsh 0-1 duodenal histology, but who had displayed a positive EmA assay in the culture medium of the duodenal biopsies (EmA-biopsy).
NCWS patients with negative EmA-biopsy.
The investigators will include exclusively patients who had been previously fully evaluated for suspected celiac disease in our Hospitals (Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca, Agrigento, and of Internal Medicine of the University of Palermo) from January 2002 to December 2012. In all patients NCWS diagnosis had been posed by means of a double-blind placebo-controlled (DBPC) challenge with wheat flour.
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, 92019, Italy
Department of Internal Medicine, University Hospital of Palermo
Palermo, 90129, Italy
Carroccio A, Iacono G, Di Prima L, Pirrone G, Cavataio F, Ambrosiano G, Sciume C, Geraci G, Florena A, Teresi S, Barbaria F, Pepe I, Campisi G, Mansueto P, Soresi M, Di Fede G. Antiendomysium antibodies assay in the culture medium of intestinal mucosa: an accurate method for celiac disease diagnosis. Eur J Gastroenterol Hepatol. 2011 Nov;23(11):1018-23. doi: 10.1097/MEG.0b013e328349b8a5.
Carroccio A, Iacono G, D'Amico D, Cavataio F, Teresi S, Caruso C, Di PL, Colombo A, D'Arpa F, Florena A, Notarbartolo A, Montalto G. Production of anti-endomysial antibodies in cultured duodenal mucosa: usefulness in coeliac disease diagnosis. Scand J Gastroenterol. 2002 Jan;37(1):32-8. doi: 10.1080/003655202753387329.
Antonio Carroccio, MD, PhD
University of Palermo
Pasquale Mansueto, MD
University of Palermo
50 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2014
First Posted
July 29, 2014
Study Start
January 1, 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 1, 2016
Actual (reported)Study Completion
June 1, 2020
Actual (reported)Last Updated
October 8, 2020
Record last verified: 2020-10
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