<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/NCT03017274</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM20</org_study_id>
    <nct_id>NCT03017274</nct_id>
  </id_info>
  <brief_title>Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity</brief_title>
  <official_title>Abdominal Ultrasound Examination in Patients Affected With Non-celiac Wheat Sensitivity</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>
      Recently 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 CD or wheat allergy. This clinical condition has been named Non-Celiac&#xD;
      Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term&#xD;
      'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes&#xD;
      the symptoms in NCGS patients, and the investigators also showed that these patients had a&#xD;
      high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is&#xD;
      characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or&#xD;
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and&#xD;
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'&#xD;
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,&#xD;
      and anemia). Nowadays no data are available on the abdominal ultrasonographic features of&#xD;
      NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal&#xD;
      ultrasonographic features of NCWS patients in comparison with patients affected with celiac&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently 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 CD or wheat allergy. This clinical condition has been named Non-Celiac&#xD;
      Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term&#xD;
      'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes&#xD;
      the symptoms in NCGS patients, and the investigators also showed that these patients had a&#xD;
      high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is&#xD;
      characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or&#xD;
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and&#xD;
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'&#xD;
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,&#xD;
      and anemia). The researchers have just demonstrated in patients affected with seronegative&#xD;
      celiac disease that the presence of dilated bowel loops and a thickened small bowel wall had&#xD;
      a sensitivity of 83% and a negative predictive value of 95% in CD diagnosis. Considering the&#xD;
      presence of one of these two signs, abdominal US sensitivity increased to 92% and negative&#xD;
      predictive value to 98%. Nowadays no data are available on the abdominal ultrasonographic&#xD;
      features of NCWS patients. Therefore, the aim of the present study is to evaluate the&#xD;
      abdominal ultrasonographic features of NCWS patients in comparison with patients affected&#xD;
      with celiac disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominal ultrasonographic features of NCWS and CD patients</measure>
    <time_frame>from January 2015 to November 2016</time_frame>
    <description>Evaluation of abdominal ultrasonographic differences between NCWS and CD patients.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Non-celiac Wheat Sensitivity</condition>
  <arm_group>
    <arm_group_label>NCWS patients</arm_group_label>
    <description>Fifty consecutive adult patients with an IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients was recruited between January 2015 and November 2016 at 2 centers: the Department of Internal Medicine at the University Hospital of Palermo, Italy, and the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD control patients</arm_group_label>
    <description>To compare the abdominal ultrasonographic features of NCWS patients, a control group of CD patients was randomly chosen by a computer-generated method from subjects diagnosed during the same period and age- and sex-matched with the NCWS patients. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Abdominal ultrasound examination</intervention_name>
    <description>All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.</description>
    <arm_group_label>CD control patients</arm_group_label>
    <arm_group_label>NCWS patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included consecutive adult patients with IBS-like clinical presentation,&#xD;
        according to Rome III criteria, and a definitive diagnosis of NCWS, referred at the&#xD;
        Department of Internal Medicine at the University Hospital of Palermo, Italy, and at the&#xD;
        Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy, between&#xD;
        January 2015 and November 2016, and sex- and age-matched subjects with CD, enrolled at the&#xD;
        same centers, as controls patients. All subjects undergone abdominal ultrasonography at the&#xD;
        Outpatient of Ultrasonography of the Department of Internal Medicine at the University&#xD;
        Hospital of Palermo, Italy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet&#xD;
        the following criteria:&#xD;
&#xD;
          -  negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA)&#xD;
             immunoglobulin (Ig)A and IgG antibodies&#xD;
&#xD;
          -  absence of intestinal villous atrophy&#xD;
&#xD;
          -  negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum&#xD;
             specific IgE detection)&#xD;
&#xD;
          -  resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's&#xD;
             milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms&#xD;
&#xD;
          -  symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the&#xD;
             investigators previously described in other studies, DBPC cow's milk protein challenge&#xD;
             and other &quot;open&quot; food challenges will be performed too.&#xD;
&#xD;
        To diagnose CD the standard criteria will be adopted. All the patients will meet the&#xD;
        following criteria:&#xD;
&#xD;
          -  positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA)&#xD;
             immunoglobulin (Ig)A and IgG antibodies&#xD;
&#xD;
          -  presence of intestinal villous atrophy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        NCWS diagnosis excluded patients with:&#xD;
&#xD;
          -  positive EmA in the culture medium of the duodenal biopsies, also in the case of&#xD;
             normal villi/crypts ratio in the duodenal mucosa&#xD;
&#xD;
          -  self-exclusion of wheat from the diet and refusal to reintroduce it before entering&#xD;
             the study&#xD;
&#xD;
          -  other previously diagnosed gastrointestinal disorders&#xD;
&#xD;
          -  nervous system disease and/or major psychiatric disorder&#xD;
&#xD;
          -  physical impairment limiting physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Soresi M, Pirrone G, Giannitrapani L, Iacono G, Di Prima L, La Spada E, Di Fede G, Ambrosiano G, Montalto G, Carroccio A. A key role for abdominal ultrasound examination in &quot;difficult&quot; diagnoses of celiac disease. Ultraschall Med. 2011 Jan;32 Suppl 1:S53-61. doi: 10.1055/s-0028-1110009. Epub 2010 Mar 16.</citation>
    <PMID>20235005</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 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>celiac disease</keyword>
  <keyword>abdominal ultrasonography;</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/NCT03017274
org study id: ACPM20
nct id: NCT03017274
lead sponsor: 
has dmc: No
Recently 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 CD 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). Nowadays no data are available on the abdominal ultrasonographic features of
      NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal
      ultrasonographic features of NCWS patients in comparison with patients affected with celiac
      disease.
Recently 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 CD 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). The researchers have just demonstrated in patients affected with seronegative
      celiac disease that the presence of dilated bowel loops and a thickened small bowel wall had
      a sensitivity of 83% and a negative predictive value of 95% in CD diagnosis. Considering the
      presence of one of these two signs, abdominal US sensitivity increased to 92% and negative
      predictive value to 98%. Nowadays no data are available on the abdominal ultrasonographic
      features of NCWS patients. Therefore, the aim of the present study is to evaluate the
      abdominal ultrasonographic features of NCWS patients in comparison with patients affected
      with celiac disease.
observational model: Case-Control
time perspective: Prospective
measure: Abdominal ultrasonographic features of NCWS and CD patients
time frame: from January 2015 to November 2016
description: Evaluation of abdominal ultrasonographic differences between NCWS and CD patients.
arm group label: NCWS patients
description: Fifty consecutive adult patients with an IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients was recruited between January 2015 and November 2016 at 2 centers: the Department of Internal Medicine at the University Hospital of Palermo, Italy, and the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
arm group label: CD control patients
description: To compare the abdominal ultrasonographic features of NCWS patients, a control group of CD patients was randomly chosen by a computer-generated method from subjects diagnosed during the same period and age- and sex-matched with the NCWS patients. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
intervention type: Other
intervention name: Abdominal ultrasound examination
description: All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
arm group label: CD control patients
arm group label: NCWS patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 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: Soresi M, Pirrone G, Giannitrapani L, Iacono G, Di Prima L, La Spada E, Di Fede G, Ambrosiano G, Montalto G, Carroccio A. A key role for abdominal ultrasound examination in "difficult" diagnoses of celiac disease. Ultraschall Med. 2011 Jan;32 Suppl 1:S53-61. doi: 10.1055/s-0028-1110009. Epub 2010 Mar 16.
PMID: 20235005
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: MD
mesh term: Hypersensitivity
sharing ipd: No