<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/NCT03022994</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM18</org_study_id>
    <nct_id>NCT03022994</nct_id>
  </id_info>
  <brief_title>Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients</brief_title>
  <official_title>Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients</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. Nowadays only few data are&#xD;
      available on the histological characteristic of duodenal and rectal biopsies of NCWS&#xD;
      patients. The researchers have just demonstrated a significant eosinophils infiltration of&#xD;
      the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the&#xD;
      rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse&#xD;
      gastrointestinal &quot;inflammatory/immunologic&quot; pattern. The aims of the present study are: 1) to&#xD;
      investigate the histological characteristics in duodenal and rectal biopsies between NCWS and&#xD;
      irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or&#xD;
      rectal) shows &quot;inflammatory/allergic&quot; features useful for NCWS histological diagnosis.&#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). Nowadays only few data are available on the histological characteristic of&#xD;
      duodenal and rectal biopsies of NCWS patients. The researchers have just demonstrated a&#xD;
      significant eosinophils infiltration of the duodenal and colon mucosa, and a significant&#xD;
      infiltration of CD45+/CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat&#xD;
      challenge, thus configuring a diffuse gastrointestinal &quot;inflammatory/immunologic&quot; pattern. As&#xD;
      regard to rectal lymphocytes, analysis of cytokine production demonstrated dominant&#xD;
      spontaneous interferon (IFN)-γ production by these cells, which were further identified as&#xD;
      innate lymphoid cells belonging to the group 1 (ILC1) population, expressing T-bet and&#xD;
      producing IFN-γ, compatible to an innate immunity involvement in NCWS pathogenesis.&#xD;
      Therefore, the aims of the present study are: 1) to investigate the histological&#xD;
      characteristics and differences in duodenal and rectal biopsies between NCWS and IBS&#xD;
      patients, and 2) to search for &quot;inflammatory/allergic&quot; features (i.e. eosinophils and/or&#xD;
      lymphocytes infiltration) useful for NCWS histological diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Histological differences in duodenal biopsies between NCWS and IBS patients.</measure>
    <time_frame>July 2016 to February 2017</time_frame>
    <description>Histological characteristics and differences in duodenal biopsies between NCWS and IBS patients, with particular reference to lymphocytes, plasmacells, eosinophils and mast cells (i.e. number of cells for high power field).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histological differences in rectal biopsies between NCWS and IBS patients.</measure>
    <time_frame>July 2016 to February 2017</time_frame>
    <description>Histological characteristics and differences in rectal biopsies between NCWS and IBS patients, with particular reference to lymphocytes, plasmacells, eosinophils and mast cells (i.e. number of cells for high power field).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of site (i.e. duodenal or rectal) with more inflammatory cells infiltration.</measure>
    <time_frame>July 2016 to February 2017</time_frame>
    <description>Evaluation of which examined site (i.e. duodenal or rectal) presents more lymphocytes and/or eosinophils infiltration (i.e. number of cells for high power field), for NCWS histological diagnosis.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Non-celiac Wheat Sensitivity</condition>
  <arm_group>
    <arm_group_label>NCWS patients</arm_group_label>
    <description>Forty consecutive adult patients with an IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients will be recruited between January 2016 and February 2017 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 will undergo upper gastrointestinal endoscopy and proctoscopy at the Gastroenterology Unit at the University Hospital of Palermo, Italy. Duodenal and rectal biopsies will be evaluated at 2 centers: the Pathology Unit at the University Hospital of Palermo, Italy, and the Institute of Pathology at the &quot;Spedali Civili&quot; of Brescia, Italy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBS patients</arm_group_label>
    <description>Forty sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled, at the same 2 centers, as control group. All subjects will undergo upper gastrointestinal endoscopy and proctoscopy at the Gastroenterology Unit at the University Hospital of Palermo, Italy. Duodenal and rectal biopsies will be evaluated at 2 centers: the Pathology Unit at the University Hospital of Palermo, Italy, and the Institute of Pathology at the &quot;Spedali Civili&quot; of Brescia, Italy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Duodenum and rectum examination</intervention_name>
    <description>All subjects will undergo upper gastrointestinal endoscopy and proctoscopy. In addition, it will be also evaluated duodenal and rectal biopsies.</description>
    <arm_group_label>IBS patients</arm_group_label>
    <arm_group_label>NCWS patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsy specimens obtained from the bulb and the second duodenal portion and the rectum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 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 July&#xD;
        2016 to February 2017, and sex- and age-matched subjects with IBS, enrolled at the same&#xD;
        centers, as controls patients. All subjects will undergo upper gastrointestinal endoscopy&#xD;
        and proctoscopy at the Gastroenterology Unit at the University Hospital of Palermo.&#xD;
        Duodenal and rectal biopsies will be evaluated at 2 centers: the Pathology Unit at the&#xD;
        University Hospital of Palermo, Italy, and the Institute of Pathology, Spedali Civili&#xD;
        Brescia, Brescia, 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 IBS the standard Rome II (for retrospective patients) and Rome III (for&#xD;
        prospective patients) Criteria will be adopted. None of these subjects improved on an&#xD;
        elimination diet without wheat, cow's milk, egg, tomato, or chocolate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        NCWS diagnosis will be excluded by:&#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;
          -  other previously diagnosed gynaecological 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>Di Liberto D, Mansueto P, D'Alcamo A, Lo Pizzo M, Lo Presti E, Geraci G, Fayer F, Guggino G, Iacono G, Dieli F, Carroccio A. Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet. Clin Transl Gastroenterol. 2016 Jul 7;7(7):e178. doi: 10.1038/ctg.2016.35.</citation>
    <PMID>27388423</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 9, 2017</last_update_submitted>
  <last_update_submitted_qc>July 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 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>eosinophils</keyword>
  <keyword>lymphocytes</keyword>
  <keyword>duodenal biopsies</keyword>
  <keyword>rectal biopsies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <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/NCT03022994
org study id: ACPM18
nct id: NCT03022994
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. Nowadays only few data are
      available on the histological characteristic of duodenal and rectal biopsies of NCWS
      patients. The researchers have just demonstrated a significant eosinophils infiltration of
      the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the
      rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse
      gastrointestinal "inflammatory/immunologic" pattern. The aims of the present study are: 1) to
      investigate the histological characteristics in duodenal and rectal biopsies between NCWS and
      irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or
      rectal) shows "inflammatory/allergic" features useful for NCWS histological diagnosis.
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 only few data are available on the histological characteristic of
      duodenal and rectal biopsies of NCWS patients. The researchers have just demonstrated a
      significant eosinophils infiltration of the duodenal and colon mucosa, and a significant
      infiltration of CD45+/CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat
      challenge, thus configuring a diffuse gastrointestinal "inflammatory/immunologic" pattern. As
      regard to rectal lymphocytes, analysis of cytokine production demonstrated dominant
      spontaneous interferon (IFN)-γ production by these cells, which were further identified as
      innate lymphoid cells belonging to the group 1 (ILC1) population, expressing T-bet and
      producing IFN-γ, compatible to an innate immunity involvement in NCWS pathogenesis.
      Therefore, the aims of the present study are: 1) to investigate the histological
      characteristics and differences in duodenal and rectal biopsies between NCWS and IBS
      patients, and 2) to search for "inflammatory/allergic" features (i.e. eosinophils and/or
      lymphocytes infiltration) useful for NCWS histological diagnosis.
observational model: Case-Control
time perspective: Prospective
measure: Histological differences in duodenal biopsies between NCWS and IBS patients.
time frame: July 2016 to February 2017
description: Histological characteristics and differences in duodenal biopsies between NCWS and IBS patients, with particular reference to lymphocytes, plasmacells, eosinophils and mast cells (i.e. number of cells for high power field).
measure: Histological differences in rectal biopsies between NCWS and IBS patients.
time frame: July 2016 to February 2017
description: Histological characteristics and differences in rectal biopsies between NCWS and IBS patients, with particular reference to lymphocytes, plasmacells, eosinophils and mast cells (i.e. number of cells for high power field).
measure: Identification of site (i.e. duodenal or rectal) with more inflammatory cells infiltration.
time frame: July 2016 to February 2017
description: Evaluation of which examined site (i.e. duodenal or rectal) presents more lymphocytes and/or eosinophils infiltration (i.e. number of cells for high power field), for NCWS histological diagnosis.
arm group label: NCWS patients
description: Forty consecutive adult patients with an IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients will be recruited between January 2016 and February 2017 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 will undergo upper gastrointestinal endoscopy and proctoscopy at the Gastroenterology Unit at the University Hospital of Palermo, Italy. Duodenal and rectal biopsies will be evaluated at 2 centers: the Pathology Unit at the University Hospital of Palermo, Italy, and the Institute of Pathology at the "Spedali Civili" of Brescia, Italy.
arm group label: IBS patients
description: Forty sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled, at the same 2 centers, as control group. All subjects will undergo upper gastrointestinal endoscopy and proctoscopy at the Gastroenterology Unit at the University Hospital of Palermo, Italy. Duodenal and rectal biopsies will be evaluated at 2 centers: the Pathology Unit at the University Hospital of Palermo, Italy, and the Institute of Pathology at the "Spedali Civili" of Brescia, Italy.
intervention type: Other
intervention name: Duodenum and rectum examination
description: All subjects will undergo upper gastrointestinal endoscopy and proctoscopy. In addition, it will be also evaluated duodenal and rectal biopsies.
arm group label: IBS patients
arm group label: NCWS patients
Biopsy specimens obtained from the bulb and the second duodenal portion and the rectum.
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: Di Liberto D, Mansueto P, D'Alcamo A, Lo Pizzo M, Lo Presti E, Geraci G, Fayer F, Guggino G, Iacono G, Dieli F, Carroccio A. Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet. Clin Transl Gastroenterol. 2016 Jul 7;7(7):e178. doi: 10.1038/ctg.2016.35.
PMID: 27388423
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: MD
mesh term: Irritable Bowel Syndrome
mesh term: Hypersensitivity
sharing ipd: No