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/NCT04154137
NCT04154137N/ACompleted

Prevalence of Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy

University of Palermo·observational·Posted Nov 6, 2019·Updated Jan 18, 2020

In Brief

An observational study evaluating Questionnaire for Non-celiac Wheat Sensitivity. Completed, enrolled 500 participants across 3 sites.

Detailed Summary

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.

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartJan 1, 2017
Primary CompletionJun 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.7 years ago

Interventions

Questionnaireother

Enrolled patients will fill out a modified version of a previously validated written questionnaire, including two different sections. The first comprises 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, allergic and psychiatric history. The second section enquires for self-reported gluten-related symptoms. Participants will be 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 is defined by those who had a doctor diagnosis of celiac disease and wheat allergy and are also taking a gluten-free diet.