- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03021148
Self-reported Gluten Sensitivity in High-school Students
January 11, 2017 updated by: Pasquale Mansueto, University of Palermo
Prevalence of Self-reported Gluten Sensitivity in a Population of High-school Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Self-reported food hypersensitivity is common, particularly in women, with a reported prevalence of 20.4% 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.
The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia).
To our knowledge, there are 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 shown 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.
In this study individuals self-reporting gluten-related symptoms are predominantly female, report an association with IBS, and experience both intestinal and extraintestinal symptoms on gluten ingestion.
Of those patients presenting to the gastroenterology department, the majority do not have CD but NCWS.
In contrast to the above mentioned data, obtained in adults, no data are available for young people.
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.
The students participated in the study by filling out a modified version of a previously validated written questionnaire, to which there were two sections.
The first comprised basic demographic information, including age, sex and ethnicity, and a screening section for symptoms consistent with irritable bowel syndrome (IBS) in accordance with the Rome III criteria, also including their past gastrointestinal, psychiatric and allergic history.
The second section of the survey enquired for self-reported gluten-related symptoms.
Participants were also asked for their use of a gluten-free diet and if they had seen a healthcare professional for their symptoms.
A reported diagnosis of celiac disease and wheat allergy in the population group was defined by those who had a doctor diagnosis of celiac disease and wheat allergy and were also taking a gluten-free diet.
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Palermo, Italy, 90129
- Department of Internal Medicine, University Hospital of Palermo
-
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Agrigento
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Sciacca, Agrigento, Italy, 92019
- Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study include high-school children, age range from 13 to 18 years, from "Liceo Classico" and "Liceo Artistico" "Tommaso Fazello" of Sciacca, Agrigento, Italy, evaluated by an ad hoc questionnaire between January 2016 and December 2016.
Description
Inclusion Criteria:
- All students who attended the high-school five-years course, independently by their age.
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High-school children
High-school children, age range from 13 to 18 years, from "Liceo Classico" and "Liceo Artistico" "Tommaso Fazello" of Sciacca, Agrigento, Italy
|
Administration of questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with self-perceived gluten-sensitivity in a population of high-school students
Time Frame: January 2016 to December 2016
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic differences between children self-reporting and children not self reporting gluten-related symptoms
Time Frame: January 2016 to December 2016
|
Demographic differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity
|
January 2016 to December 2016
|
Clinical differences between children self-reporting and children not self reporting gluten-related symptoms
Time Frame: January 2016 to December 2016
|
Clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity
|
January 2016 to December 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
- 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.
- 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. No abstract available.
- Carroccio A, Soresi M, D'Alcamo A, Sciume 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. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
- 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. No abstract available.
- Young E, Stoneham MD, Petruckevitch A, Barton J, Rona R. A population study of food intolerance. Lancet. 1994 May 7;343(8906):1127-30. doi: 10.1016/s0140-6736(94)90234-8.
- 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 Jan;26(1):33-9. doi: 10.1097/01.meg.0000435546.87251.f7.
- 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. doi: 10.1097/00042737-200304000-00012.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 30, 2016
First Submitted That Met QC Criteria
January 11, 2017
First Posted (Estimate)
January 13, 2017
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACPM17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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