Non-celiac Wheat Sensitivity Clinical Trial
Official title:
Prevalence of Self-reported Gluten Sensitivity in a Population of High-school Students
Verified date | January 2017 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Observational |
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. To our knowledge, there are very few studies which assessed the prevalence of self-reported gluten-related symptoms in the community and analyze diagnostic outcomes in those referred to secondary gastrointestinal care. In one of these, performed in UK, the authors showed that gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac disease. Of those patients presenting to the gastroenterology department, the majority do not have CD but NCWS. No data are available for boys and girls. Therefore, the aims of this study were 1) to determine the prevalence of self-perceived gluten-sensitivity in a population of high-school students, and 2) to evaluate the demographic and clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity.
Status | Completed |
Enrollment | 500 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility |
Inclusion Criteria: - All students who attended the high-school five-years course, independently by their age. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Department of Internal Medicine, University Hospital of Palermo | Palermo | |
Italy | Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca | Sciacca | Agrigento |
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. — 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. — 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. 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 | Number of subjects with self-perceived gluten-sensitivity in a population of high-school students | Number of subjects with self-perceived gluten-sensitivity in a population of high-school students by using an ad hoc questionnaire. | January 2016 to December 2016 | Yes |
Secondary | Demographic differences between children self-reporting and children not self reporting gluten-related symptoms | Demographic differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity | January 2016 to December 2016 | Yes |
Secondary | Clinical differences between children self-reporting and children not self reporting gluten-related symptoms | Clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity | January 2016 to December 2016 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05469971 -
KIR Genes and Non-Celiac Wheat Sensitivity
|
||
Completed |
NCT02421783 -
Osteoporosis In Non-Celiac Wheat Sensitivity Patients
|
||
Completed |
NCT02421809 -
Oral Lesions In Non-Celiac Wheat Sensitivity Patients
|
||
Completed |
NCT02421796 -
Malnutrition In Non-Celiac Wheat Sensitivity Patients
|
||
Completed |
NCT03022513 -
Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
|
N/A | |
Completed |
NCT02823522 -
Non-Celiac Wheat Sensitivity: Permanent or Transient Condition?
|
N/A | |
Completed |
NCT02248545 -
Autoimmune Diseases And Serum Anti-Nuclear Antibodies Positivity In Non-Celiac Wheat Sensitivity Patients
|
N/A | |
Completed |
NCT03022994 -
Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients
|
N/A | |
Completed |
NCT03017274 -
Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity
|
N/A | |
Recruiting |
NCT03024775 -
Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
|
N/A | |
Completed |
NCT03008252 -
Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
|
||
Completed |
NCT04154137 -
Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy
|
||
Completed |
NCT04077840 -
Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients
|
||
Completed |
NCT03027492 -
Gynaecological Disorders in Not-celiac Wheat Sensitivity
|
N/A |