<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03021148</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM17</org_study_id>
    <nct_id>NCT03021148</nct_id>
  </id_info>
  <brief_title>Self-reported Gluten Sensitivity in High-school Students</brief_title>
  <official_title>Prevalence of Self-reported Gluten Sensitivity in a Population of High-school Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Palermo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been reported that a consistent percentage of the general population consider&#xD;
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though&#xD;
      they do not have celiac disease or wheat allergy. This clinical condition has been named&#xD;
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the&#xD;
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat&#xD;
      causes the symptoms in NCGS patients, and the investigators also showed that these patients&#xD;
      had a high frequency of coexistent multiple food hypersensitivity. To our knowledge, there&#xD;
      are very few studies which assessed the prevalence of self-reported gluten-related symptoms&#xD;
      in the community and analyze diagnostic outcomes in those referred to secondary&#xD;
      gastrointestinal care. In one of these, performed in UK, the authors showed that&#xD;
      gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a&#xD;
      gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac&#xD;
      disease. Of those patients presenting to the gastroenterology department, the majority do not&#xD;
      have CD but NCWS. No data are available for boys and girls. Therefore, the aims of this study&#xD;
      were 1) to determine the prevalence of self-perceived gluten-sensitivity in a population of&#xD;
      high-school students, and 2) to evaluate the demographic and clinical differences between&#xD;
      students self-reporting gluten sensitivity and students not reporting food hypersensitivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Self-reported food hypersensitivity is common, particularly in women, with a reported&#xD;
      prevalence of 20.4% in the UK community. A wide range of gastrointestinal and systemic&#xD;
      symptoms may be experienced related to consumption of the intolerant food(s). In addition,&#xD;
      patients demonstrate considerably more generalized subjective health complaints in comparison&#xD;
      with healthy controls. In this context, it has been reported that a consistent percentage of&#xD;
      the general population consider themselves to be suffering from problems caused by wheat&#xD;
      and/or gluten ingestion, even though they do not have celiac disease or wheat allergy. This&#xD;
      clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper&#xD;
      the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not&#xD;
      known what component of wheat causes the symptoms in NCGS patients, and the investigators&#xD;
      also showed that these patients had a high frequency of coexistent multiple food&#xD;
      hypersensitivity. The clinical picture of NCWS is characterized by combined gastrointestinal&#xD;
      (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain,&#xD;
      gastroesophageal reflux, aphthous stomatitis) and extra-intestinal and/or systemic&#xD;
      manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin&#xD;
      rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). To our&#xD;
      knowledge, there are few studies which assessed the prevalence of self-reported&#xD;
      gluten-related symptoms in the community and analyze diagnostic outcomes in those referred to&#xD;
      secondary gastrointestinal care. In one of these, performed in UK, the authors shown that&#xD;
      gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a&#xD;
      gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac&#xD;
      disease. In this study individuals self-reporting gluten-related symptoms are predominantly&#xD;
      female, report an association with IBS, and experience both intestinal and extraintestinal&#xD;
      symptoms on gluten ingestion. Of those patients presenting to the gastroenterology&#xD;
      department, the majority do not have CD but NCWS. In contrast to the above mentioned data,&#xD;
      obtained in adults, no data are available for young people. Therefore, the aims of this study&#xD;
      were 1) to determine the prevalence of self-perceived gluten-sensitivity in a population of&#xD;
      high-school students, and 2) to evaluate the demographic and clinical differences between&#xD;
      students self-reporting gluten sensitivity and students not reporting food hypersensitivity.&#xD;
      The students participated in the study by filling out a modified version of a previously&#xD;
      validated written questionnaire, to which there were two sections. The first comprised basic&#xD;
      demographic information, including age, sex and ethnicity, and a screening section for&#xD;
      symptoms consistent with irritable bowel syndrome (IBS) in accordance with the Rome III&#xD;
      criteria, also including their past gastrointestinal, psychiatric and allergic history. The&#xD;
      second section of the survey enquired for self-reported gluten-related symptoms. Participants&#xD;
      were also asked for their use of a gluten-free diet and if they had seen a healthcare&#xD;
      professional for their symptoms. A reported diagnosis of celiac disease and wheat allergy in&#xD;
      the population group was defined by those who had a doctor diagnosis of celiac disease and&#xD;
      wheat allergy and were also taking a gluten-free diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with self-perceived gluten-sensitivity in a population of high-school students</measure>
    <time_frame>January 2016 to December 2016</time_frame>
    <description>Number of subjects with self-perceived gluten-sensitivity in a population of high-school students by using an ad hoc questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic differences between children self-reporting and children not self reporting gluten-related symptoms</measure>
    <time_frame>January 2016 to December 2016</time_frame>
    <description>Demographic differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical differences between children self-reporting and children not self reporting gluten-related symptoms</measure>
    <time_frame>January 2016 to December 2016</time_frame>
    <description>Clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Non-celiac Wheat Sensitivity</condition>
  <arm_group>
    <arm_group_label>High-school children</arm_group_label>
    <description>High-school children, age range from 13 to 18 years, from &quot;Liceo Classico&quot; and &quot;Liceo Artistico&quot; &quot;Tommaso Fazello&quot; of Sciacca, Agrigento, Italy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Administration of questionnaire.</description>
    <arm_group_label>High-school children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study include high-school children, age range from 13 to 18 years, from &quot;Liceo&#xD;
        Classico&quot; and &quot;Liceo Artistico&quot; &quot;Tommaso Fazello&quot; of Sciacca, Agrigento, Italy, evaluated&#xD;
        by an ad hoc questionnaire between January 2016 and December 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All students who attended the high-school five-years course, independently by their&#xD;
             age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Carroccio, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Palermo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca</name>
      <address>
        <city>Sciacca</city>
        <state>Agrigento</state>
        <zip>92019</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Internal Medicine, University Hospital of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.</citation>
    <PMID>22825366</PMID>
  </results_reference>
  <results_reference>
    <citation>Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.</citation>
    <PMID>24533607</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.</citation>
    <PMID>24275240</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.</citation>
    <PMID>25625764</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.</citation>
    <PMID>25430806</PMID>
  </results_reference>
  <results_reference>
    <citation>Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.</citation>
    <PMID>25694210</PMID>
  </results_reference>
  <results_reference>
    <citation>Young E, Stoneham MD, Petruckevitch A, Barton J, Rona R. A population study of food intolerance. Lancet. 1994 May 7;343(8906):1127-30. doi: 10.1016/s0140-6736(94)90234-8.</citation>
    <PMID>7910231</PMID>
  </results_reference>
  <results_reference>
    <citation>Aziz I, Lewis NR, Hadjivassiliou M, Winfield SN, Rugg N, Kelsall A, Newrick L, Sanders DS. A UK study assessing the population prevalence of self-reported gluten sensitivity and referral characteristics to secondary care. Eur J Gastroenterol Hepatol. 2014 Jan;26(1):33-9. doi: 10.1097/01.meg.0000435546.87251.f7.</citation>
    <PMID>24216570</PMID>
  </results_reference>
  <results_reference>
    <citation>Sanders DS, Patel D, Stephenson TJ, Ward AM, McCloskey EV, Hadjivassiliou M, Lobo AJ. A primary care cross-sectional study of undiagnosed adult coeliac disease. Eur J Gastroenterol Hepatol. 2003 Apr;15(4):407-13. doi: 10.1097/00042737-200304000-00012.</citation>
    <PMID>12655262</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Pasquale Mansueto</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Non-celiac wheat sensitivity</keyword>
  <keyword>self-reported</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021148
org study id: ACPM17
nct id: NCT03021148
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Number of subjects with self-perceived gluten-sensitivity in a population of high-school students
time frame: January 2016 to December 2016
description: Number of subjects with self-perceived gluten-sensitivity in a population of high-school students by using an ad hoc questionnaire.
measure: Demographic differences between children self-reporting and children not self reporting gluten-related symptoms
time frame: January 2016 to December 2016
description: Demographic differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity
measure: Clinical differences between children self-reporting and children not self reporting gluten-related symptoms
time frame: January 2016 to December 2016
description: Clinical differences between students self-reporting gluten sensitivity and students not reporting food hypersensitivity
arm group label: High-school children
description: High-school children, age range from 13 to 18 years, from "Liceo Classico" and "Liceo Artistico" "Tommaso Fazello" of Sciacca, Agrigento, Italy
intervention type: Other
intervention name: Questionnaire
description: Administration of questionnaire.
arm group label: High-school children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: Antonio Carroccio, PhD
role: Study Director
affiliation: University of Palermo
facility: 
facility: 
country: Italy
citation: Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
PMID: 22825366
citation: Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.
PMID: 24533607
citation: Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
PMID: 24275240
citation: Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.
PMID: 25625764
citation: Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
PMID: 25430806
citation: Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.
PMID: 25694210
citation: Young E, Stoneham MD, Petruckevitch A, Barton J, Rona R. A population study of food intolerance. Lancet. 1994 May 7;343(8906):1127-30. doi: 10.1016/s0140-6736(94)90234-8.
PMID: 7910231
citation: Aziz I, Lewis NR, Hadjivassiliou M, Winfield SN, Rugg N, Kelsall A, Newrick L, Sanders DS. A UK study assessing the population prevalence of self-reported gluten sensitivity and referral characteristics to secondary care. Eur J Gastroenterol Hepatol. 2014 Jan;26(1):33-9. doi: 10.1097/01.meg.0000435546.87251.f7.
PMID: 24216570
citation: Sanders DS, Patel D, Stephenson TJ, Ward AM, McCloskey EV, Hadjivassiliou M, Lobo AJ. A primary care cross-sectional study of undiagnosed adult coeliac disease. Eur J Gastroenterol Hepatol. 2003 Apr;15(4):407-13. doi: 10.1097/00042737-200304000-00012.
PMID: 12655262
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: MD
mesh term: Hypersensitivity
sharing ipd: No