Non-celiac Wheat Sensitivity Clinical Trial
Official title:
Oral Lesions In Non-Celiac Wheat Sensitivity Patients
NCT number | NCT02421809 |
Other study ID # | ACPM09 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2015 |
Est. completion date | June 1, 2020 |
Verified date | October 2020 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of oral lesions in NCWS. Our study aims to evaluate the prevalence of oral lesions in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)- like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent oral examination to assess the presence or not of oral soft and hard tissue lesions potentially associated to NCWS and CD.
Status | Completed |
Enrollment | 270 |
Est. completion date | June 1, 2020 |
Est. primary completion date | October 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Antonio Carroccio | Agrigento | |
Italy | Pasquale Mansueto | Palermo |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Italy,
Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndro — View Citation
Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. — View Citation
Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5. Review. — View Citation
Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. A — View Citation
Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. — View Citation
Carroccio A, Soresi M, D'Alcamo A, Sciumè C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. — View Citation
Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996. Review. — View Citation
Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in oral lesion (composite outcome) | All patients will undergo oral examination to assess the presence or not of oral soft and hard tissue lesions potentially associated to NCWS and CD. This study will be performed by Dental Clinics and the patients will be clinically examined by calibrated dentists. Dental caries at cavity level, fillings and extractions due to caries will be reported and the DMFT/DMFS (Decayed Missing Filled Teeth/Decay Missing Filled Surfaces) indexes will be assessed following the WHO diagnostic criteria of 1997. Enamel hypoplasia will be diagnosed according to Molar-Incisor Hypomineralisation (MIH). Calibration will be previously made on a sample of 20 subjects unless kappa values higher than 0,8 will be obtained for both caries and hypomineralisation. Attention will also be paid to patients with some other oral lesions, such as recurrent aphthous stomatitis (RAS), symmetric and systematic dental enamel defects, and non-specific atrophic glossitis. | At baseline and after 24 months |
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