Self-reported Gluten Sensitivity in High-school Students

Completed

• Conditions: Non-celiac Wheat Sensitivity
• Interventions: Other: Questionnaire

• Registration Number: NCT03021148
• Lead Sponsor: University of Palermo

Brief 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.

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 Timeline

• Study Start: 2016-01
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Study First Submitted: 2016-12-30
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-13
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All students who attended the high-school five-years course, independently by their age.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-school children	Questionnaire	High-school children, age range from 13 to 18 years, from "Liceo Classico" and "Liceo Artistico" "Tommaso Fazello" of Sciacca, Agrigento, Italy

Primary Outcome Measures

Name	Time	Method
Number of subjects with self-perceived gluten-sensitivity in a population of high-school students	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.

Secondary Outcome Measures

Name	Time	Method
Demographic differences between children self-reporting and children not self reporting gluten-related symptoms	January 2016 to December 2016	Demographic differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity
Clinical differences between children self-reporting and children not self reporting gluten-related symptoms	January 2016 to December 2016	Clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity

Trial Locations

Locations (2)

Department of Internal Medicine, University Hospital of Palermo; 🇮🇹 Palermo, Italy

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca; 🇮🇹 Sciacca, Agrigento, Italy