<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/NCT03024775</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM16</org_study_id>
    <nct_id>NCT03024775</nct_id>
  </id_info>
  <brief_title>Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity</brief_title>
  <official_title>Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-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>
      Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal&#xD;
      symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat&#xD;
      allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.&#xD;
      Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine&#xD;
      inhibitors, ATIs) can cause the symptoms, and therefore the term &quot;non-celiac wheat&#xD;
      sensitivity&quot; (NCWS) has been proposed instead of NCGS. It is believed that this condition is&#xD;
      worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with&#xD;
      high gluten content), and that ancient wheats are better tolerated by NCWS patients than the&#xD;
      modern ones. Therefore, the aim of the study is to determine whether the common belief&#xD;
      regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern&#xD;
      ones is confirmed by scientific data, and to identify the wheat kernel components triggering&#xD;
      this pathology. The availability of wheat materials with opposite characteristics, such as&#xD;
      the period of development (ancient vs. modern), or the technological properties (cultivars&#xD;
      with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides,&#xD;
      will allow to define the role played by these factors. Therefore, the study has two&#xD;
      objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the&#xD;
      inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells&#xD;
      (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control&#xD;
      subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the&#xD;
      previous in vitro studies, showing the highest and the lowest in vitro inflammatory response,&#xD;
      in order to verify their effect in triggering NCWS symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal&#xD;
      symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat&#xD;
      allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.&#xD;
      Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine&#xD;
      inhibitors, ATIs) can cause the symptoms, and therefore the term &quot;non-celiac wheat&#xD;
      sensitivity&quot; (NCWS) has been proposed instead of NCGS. NCWS pathogenesis has been attributed&#xD;
      to very different mechanisms: innate or adaptive immunity, incomplete digestion and/or&#xD;
      absorption of fermentable oligosaccharides and disaccharides, monosaccharides and polyols,&#xD;
      and, finally, psychological effect. In addition, it is believed that this condition is&#xD;
      worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with&#xD;
      high gluten content), and that ancient wheats are better tolerated by NCWS patients than the&#xD;
      modern ones. Therefore, the aim of the study is to determine whether the common belief&#xD;
      regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern&#xD;
      ones is confirmed by scientific data, and to identify the wheat kernel components triggering&#xD;
      this pathology. The availability of wheat materials with opposite characteristics, such as&#xD;
      the period of development (ancient vs. modern), or the technological properties (cultivars&#xD;
      with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides,&#xD;
      will allow to define the role played by these factors. The researchers take into&#xD;
      consideration different tetraploid wheat genotypes derived from the Italian breeding activity&#xD;
      carried out during the 20th century in comparison with landraces, primitive and old wheat&#xD;
      cultivars previously cultivated and used mostly in Southern Italy for pasta and bread&#xD;
      production, together with an experimental genetically modified (GM) wheat line expressing a&#xD;
      lower amount of ATIs. For the purpose of the study, the collection has been subdivided into 5&#xD;
      groups, according to the breeding period. Wheat genotypes will be also evaluated for several&#xD;
      parameters: protein content, gluten index, quantitative analysis of ATIs proteins by Mass&#xD;
      Spectrometry, etc. The project has two objectives, related to the influence of wheat&#xD;
      consumption on health: 1) extraction and testing of total kernel proteins, in order to&#xD;
      evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood&#xD;
      mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and&#xD;
      healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the&#xD;
      basis of the previous in vitro studies, showing the highest and the lowest in vitro&#xD;
      inflammatory response, in order to verify their effect in triggering NCWS symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammatory response to wheat genotypes by PBMC of NCWS patients and healthy control subjects.</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Cytokines evaluation in response to gluten and non-gluten proteins from total kernel proteins of different wheat genotypes (i.e. ancient vs. modern vs. genetically modified) by PBMC of patients with a definitive diagnosis of NCWS, at the end of the diagnostic Double-Blind Placebo-Controlled (DBPC) wheat challenge, and of healthy control subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory response to wheat genotypes by rectal immunocytes of NCWS patients and healthy control subjects.</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Rectal immunocytes evaluation in response to gluten and non-gluten proteins from total kernel proteins of different wheat genotypes (i.e. ancient vs. modern vs. genetically modified) by immunocytes extracted by the rectal mucosa of patients with a definitive diagnosis of NCWS, at the end of the diagnostic Double-Blind Placebo-Controlled (DBPC) wheat challenge, and of healthy control subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response to wheat genotypes in NCWS patients</measure>
    <time_frame>Change from baseline at 2 weeks</time_frame>
    <description>Symptoms evaluation before and after a 2 weeks challenge with two wheat genotypes showing the highest and the lowest in vitro inflammatory response in diagnosed NCWS patients on gluten-free diet. During the challenge periods, the severity of symptoms will be recorded: the patients will complete a 100mm visual analog scale, which assesses the specific symptoms they report. The challenges will be considered positive if the same symptoms which had been initially present will reappear after their disappearance on elimination diet.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Non-celiac Wheat Sensitivity</condition>
  <arm_group>
    <arm_group_label>Active Comparator 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wheat flour with high inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wheat flour with low inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (xylose) will be administered blindly versus wheat flour with high inflammatory response for 15 days in NCWS patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (xylose) will be administered blindly versus wheat flour with low inflammatory response for 15 days in NCWS patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wheat flour</intervention_name>
    <description>Wheat flour will be administered three times per day for 15 days.</description>
    <arm_group_label>Active Comparator 1</arm_group_label>
    <arm_group_label>Active Comparator 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (xylose) will be administered three times per day for 15 days.</description>
    <arm_group_label>Placebo 1</arm_group_label>
    <arm_group_label>Placebo 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All the patients will meet the recently proposed criteria:&#xD;
&#xD;
          -  negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin&#xD;
             (Ig)A and IgG antibodies&#xD;
&#xD;
          -  absence of intestinal villous atrophy&#xD;
&#xD;
          -  IgE-mediated immunoallergic tests negative to wheat (skin prick tests and/or serum&#xD;
             specific IgE detection)&#xD;
&#xD;
          -  follow-up duration &gt;12 months after the initial diagnosis&#xD;
&#xD;
          -  at least two outpatient visits during the follow-up period.&#xD;
&#xD;
        Adjunctive criteria adopted in our patients will be:&#xD;
&#xD;
          -  resolution of the gastrointestinal symptoms on a standard elimination diet, without&#xD;
             wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported&#xD;
             symptoms&#xD;
&#xD;
          -  symptom reappearance on DBPC wheat challenge, performed as described previously. As in&#xD;
             previous studies, DBPC cow's milk protein challenge and other &quot;open&quot; food challenges&#xD;
             will be also performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria will be:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  positive EmA in the culture medium of the duodenal biopsies, even if the villi to&#xD;
             crypts ratio in the duodenal mucosa was normal&#xD;
&#xD;
          -  self-exclusion of wheat from the diet and refusal to reintroduce it before entering&#xD;
             the study&#xD;
&#xD;
          -  other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease)&#xD;
&#xD;
          -  concomitant treatment with steroids and/or antihistamines.&#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>
  <overall_contact>
    <last_name>Antonio Carroccio, PhD</last_name>
    <phone>+390916552884</phone>
    <email>acarroccio@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pasquale Mansueto, MD</last_name>
    <phone>+390916552884</phone>
    <email>pasquale.mansueto@unipa.it</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Carroccio, MD, PhD</last_name>
      <phone>+390916554347</phone>
      <email>acarroccio@hotmail.com</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Pasquale Mansueto, MD</last_name>
      <phone>+390916554347</phone>
      <email>pasquale.mansueto@unipa.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <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>
  </reference>
  <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>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>Spits H, Cupedo T. Innate lymphoid cells: emerging insights in development, lineage relationships, and function. Annu Rev Immunol. 2012;30:647-75. doi: 10.1146/annurev-immunol-020711-075053. Epub 2012 Jan 6.</citation>
    <PMID>22224763</PMID>
  </results_reference>
  <results_reference>
    <citation>Spits H, Di Santo JP. The expanding family of innate lymphoid cells: regulators and effectors of immunity and tissue remodeling. Nat Immunol. 2011 Jan;12(1):21-7. doi: 10.1038/ni.1962. Epub 2010 Nov 28.</citation>
    <PMID>21113163</PMID>
  </results_reference>
  <results_reference>
    <citation>Veldhoen M, Withers DR. Immunology. Innate lymphoid cell relations. Science. 2010 Oct 29;330(6004):594-5. doi: 10.1126/science.1198298. No abstract available.</citation>
    <PMID>21030634</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</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>ancient wheats</keyword>
  <keyword>modern wheats</keyword>
  <keyword>ATIs</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/NCT03024775
org study id: ACPM16
nct id: NCT03024775
lead sponsor: 
has dmc: No
Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal
      symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat
      allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.
      Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine
      inhibitors, ATIs) can cause the symptoms, and therefore the term "non-celiac wheat
      sensitivity" (NCWS) has been proposed instead of NCGS. It is believed that this condition is
      worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with
      high gluten content), and that ancient wheats are better tolerated by NCWS patients than the
      modern ones. Therefore, the aim of the study is to determine whether the common belief
      regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern
      ones is confirmed by scientific data, and to identify the wheat kernel components triggering
      this pathology. The availability of wheat materials with opposite characteristics, such as
      the period of development (ancient vs. modern), or the technological properties (cultivars
      with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides,
      will allow to define the role played by these factors. Therefore, the study has two
      objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the
      inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells
      (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control
      subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the
      previous in vitro studies, showing the highest and the lowest in vitro inflammatory response,
      in order to verify their effect in triggering NCWS symptoms.
Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal
      symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat
      allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.
      Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine
      inhibitors, ATIs) can cause the symptoms, and therefore the term "non-celiac wheat
      sensitivity" (NCWS) has been proposed instead of NCGS. NCWS pathogenesis has been attributed
      to very different mechanisms: innate or adaptive immunity, incomplete digestion and/or
      absorption of fermentable oligosaccharides and disaccharides, monosaccharides and polyols,
      and, finally, psychological effect. In addition, it is believed that this condition is
      worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with
      high gluten content), and that ancient wheats are better tolerated by NCWS patients than the
      modern ones. Therefore, the aim of the study is to determine whether the common belief
      regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern
      ones is confirmed by scientific data, and to identify the wheat kernel components triggering
      this pathology. The availability of wheat materials with opposite characteristics, such as
      the period of development (ancient vs. modern), or the technological properties (cultivars
      with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides,
      will allow to define the role played by these factors. The researchers take into
      consideration different tetraploid wheat genotypes derived from the Italian breeding activity
      carried out during the 20th century in comparison with landraces, primitive and old wheat
      cultivars previously cultivated and used mostly in Southern Italy for pasta and bread
      production, together with an experimental genetically modified (GM) wheat line expressing a
      lower amount of ATIs. For the purpose of the study, the collection has been subdivided into 5
      groups, according to the breeding period. Wheat genotypes will be also evaluated for several
      parameters: protein content, gluten index, quantitative analysis of ATIs proteins by Mass
      Spectrometry, etc. The project has two objectives, related to the influence of wheat
      consumption on health: 1) extraction and testing of total kernel proteins, in order to
      evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood
      mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and
      healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the
      basis of the previous in vitro studies, showing the highest and the lowest in vitro
      inflammatory response, in order to verify their effect in triggering NCWS symptoms.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Inflammatory response to wheat genotypes by PBMC of NCWS patients and healthy control subjects.
time frame: Through study completion, an average of 6 months
description: Cytokines evaluation in response to gluten and non-gluten proteins from total kernel proteins of different wheat genotypes (i.e. ancient vs. modern vs. genetically modified) by PBMC of patients with a definitive diagnosis of NCWS, at the end of the diagnostic Double-Blind Placebo-Controlled (DBPC) wheat challenge, and of healthy control subjects.
measure: Inflammatory response to wheat genotypes by rectal immunocytes of NCWS patients and healthy control subjects.
time frame: Through study completion, an average of 6 months
description: Rectal immunocytes evaluation in response to gluten and non-gluten proteins from total kernel proteins of different wheat genotypes (i.e. ancient vs. modern vs. genetically modified) by immunocytes extracted by the rectal mucosa of patients with a definitive diagnosis of NCWS, at the end of the diagnostic Double-Blind Placebo-Controlled (DBPC) wheat challenge, and of healthy control subjects.
measure: Clinical response to wheat genotypes in NCWS patients
time frame: Change from baseline at 2 weeks
description: Symptoms evaluation before and after a 2 weeks challenge with two wheat genotypes showing the highest and the lowest in vitro inflammatory response in diagnosed NCWS patients on gluten-free diet. During the challenge periods, the severity of symptoms will be recorded: the patients will complete a 100mm visual analog scale, which assesses the specific symptoms they report. The challenges will be considered positive if the same symptoms which had been initially present will reappear after their disappearance on elimination diet.
arm group label: Active Comparator 1
arm group type: Active Comparator
description: Wheat flour with high inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.
arm group label: Active Comparator 2
arm group type: Active Comparator
description: Wheat flour with low inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.
arm group label: Placebo 1
arm group type: Placebo Comparator
description: Placebo (xylose) will be administered blindly versus wheat flour with high inflammatory response for 15 days in NCWS patients.
arm group label: Placebo 2
arm group type: Placebo Comparator
description: Placebo (xylose) will be administered blindly versus wheat flour with low inflammatory response for 15 days in NCWS patients.
intervention type: Dietary Supplement
intervention name: Wheat flour
description: Wheat flour will be administered three times per day for 15 days.
arm group label: Active Comparator 1
arm group label: Active Comparator 2
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo (xylose) will be administered three times per day for 15 days.
arm group label: Placebo 1
arm group label: Placebo 2
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
last name: Antonio Carroccio, PhD
phone: +390916552884
email: acarroccio@hotmail.com
last name: Pasquale Mansueto, MD
phone: +390916552884
email: pasquale.mansueto@unipa.it
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
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, 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: 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: Spits H, Cupedo T. Innate lymphoid cells: emerging insights in development, lineage relationships, and function. Annu Rev Immunol. 2012;30:647-75. doi: 10.1146/annurev-immunol-020711-075053. Epub 2012 Jan 6.
PMID: 22224763
citation: Spits H, Di Santo JP. The expanding family of innate lymphoid cells: regulators and effectors of immunity and tissue remodeling. Nat Immunol. 2011 Jan;12(1):21-7. doi: 10.1038/ni.1962. Epub 2010 Nov 28.
PMID: 21113163
citation: Veldhoen M, Withers DR. Immunology. Innate lymphoid cell relations. Science. 2010 Oct 29;330(6004):594-5. doi: 10.1126/science.1198298. No abstract available.
PMID: 21030634
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: MD
mesh term: Hypersensitivity
sharing ipd: No