CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
Questionnaireother
Likely dose
Not stated in record
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Search/NCT03021148
NCT03021148N/ACompleted

Prevalence of Self-reported Gluten Sensitivity in a Population of High-school Students

University of Palermo·observational·Posted Jan 13, 2017·Updated Jan 13, 2017

In Brief

An observational study evaluating Questionnaire for Non-celiac Wheat Sensitivity. Completed, enrolled 500 participants across 2 sites.

Detailed Summary

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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartJan 1, 2016
Primary CompletionOct 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago

Interventions

Questionnaireother

Administration of questionnaire.