Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04154137|
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment|
|Non-celiac Wheat Sensitivity||Other: Questionnaire|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||500 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Prevalence of Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||June 1, 2019|
|Actual Study Completion Date :||January 1, 2020|
Patients undergoing digestive endoscopy
All the patients, age ranged from 18 to 90 years, referred to Digestive Endoscopy Outpatients Clinic of the Department of Gastroenterology of the University Hospital "Paolo Giaccone" of Palermo, Italy
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.
- Self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy. [ Time Frame: January 2017 to January 2020 ]Prevalence of self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy by using an ad hoc questionnaire.
- Differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity. [ Time Frame: January 2017 to January 2020 ]Demographic and clinical differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154137
|Digestive Endoscopy Outpatients Clinic of the Department of Gastroenterology of the University Hospital "Paolo Giaccone"|
|Palermo, PA, Italy, 90129|
|Internal Medicine Division of the "Cervello-Villa Sofia" Hospital|
|Palermo, PA, Italy, 90129|
|Department of Internal Medicine, University Hospital of Palermo|
|Palermo, Italy, 90129|
|Study Director:||Antonio Carroccio, PHD||University of Palermo|