Non-celiac Wheat Sensitivity Clinical Trial
Official title:
Prevalence of Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy
NCT number | NCT04154137 |
Other study ID # | ACPM23 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | January 1, 2020 |
Verified date | January 2020 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Self-reported food hypersensitivity is common, particularly in women, with a reported prevalence of about 20% in the UK community. A wide range of gastrointestinal and systemic symptoms may be experienced related to consumption of the intolerant food(s). In addition, patients demonstrate considerably more generalized subjective health complaints in comparison with healthy controls. In this context, 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 celiac disease 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. In a previous study, the investigators demonstrated, in a population of teenagers, a frequency of self-reported NCWS of about 12%; the frequency of GFD use was 2.9%, which was much higher than the percentage of known CD in the same population (1.26%). The aims of this study were 1) to determine the prevalence of self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy, irrespective to the motivations of the test, and 2) to evaluate the demographic and clinical differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity.
Status | Completed |
Enrollment | 500 |
Est. completion date | January 1, 2020 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - All patients undergoing digestive endoscopic investigations, irrespective to the motivations of the test. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Internal Medicine, University Hospital of Palermo | Palermo | |
Italy | Digestive Endoscopy Outpatients Clinic of the Department of Gastroenterology of the University Hospital "Paolo Giaccone" | Palermo | PA |
Italy | Internal Medicine Division of the "Cervello-Villa Sofia" Hospital | Palermo | PA |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Italy,
Aziz I, Lewis NR, Hadjivassiliou M, Winfield SN, Rugg N, Kelsall A, Newrick L, Sanders DS. A UK study assessing the population prevalence of self-reported gluten sensitivity and referral characteristics to secondary care. Eur J Gastroenterol Hepatol. 2014 — 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, 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
Sanders DS, Patel D, Stephenson TJ, Ward AM, McCloskey EV, Hadjivassiliou M, Lobo AJ. A primary care cross-sectional study of undiagnosed adult coeliac disease. Eur J Gastroenterol Hepatol. 2003 Apr;15(4):407-13. — View Citation
Young E, Stoneham MD, Petruckevitch A, Barton J, Rona R. A population study of food intolerance. Lancet. 1994 May 7;343(8906):1127-30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy. | Prevalence of self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy by using an ad hoc questionnaire. | January 2017 to January 2020 | |
Secondary | Differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity. | Demographic and clinical differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity. | January 2017 to January 2020 |
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