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

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ClinicalTrials.gov Identifier: NCT04154137
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo

Brief 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.

Condition or disease Intervention/treatment
Non-celiac Wheat Sensitivity Other: Questionnaire

Detailed Description:
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. 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 wheat and/or 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 were predominantly female, reported an association with IBS, and experienced 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 another 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: Questionnaire
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study will include patients undergoing digestive endoscopy (i.e. esophagogastroduodenoscopy, pancolonscopy and proctoscopy), at the Digestive Endoscopy Outpatients Clinic of the Department of Gastroenterology of the University Hospital "Paolo Giaccone" of Palermo, Italy, between January 2017 and January 2020.
Criteria

Inclusion Criteria:

  • All patients undergoing digestive endoscopic investigations, irrespective to the motivations of the test.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
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Italy
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
Sponsors and Collaborators
University of Palermo
Investigators
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Study Director: Antonio Carroccio, PHD University of Palermo
Publications of Results:

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Responsible Party: Pasquale Mansueto, Clinical Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT04154137    
Other Study ID Numbers: ACPM23
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pasquale Mansueto, University of Palermo:
non-celiac wheat sensitivity
celiac disease
wheat allergy
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases