<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/NCT03027492</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM15</org_study_id>
    <nct_id>NCT03027492</nct_id>
  </id_info>
  <brief_title>Gynaecological Disorders in Not-celiac Wheat Sensitivity</brief_title>
  <official_title>Gynaecological Disorders 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>
      In the last few years, a new clinical entity has emerged which includes patients who consider&#xD;
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though&#xD;
      they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named&#xD;
      non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators&#xD;
      suggested the term &quot;non-celiac wheat sensitivity&quot; (NCWS), because it is not known to date&#xD;
      what component of wheat actually causes the symptoms. 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 very&#xD;
      different extra-intestinal and systemic manifestations (headache, depression, anxiety, 'foggy&#xD;
      mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm&#xD;
      numbness, and anemia). Nowadays, there no data about a possible relationship between&#xD;
      gynaecological disorders and food ingestion and food allergy/intolerance. Therefore, the aims&#xD;
      of the present study are to investigate 1) the prevalence and characteristics of&#xD;
      gynaecological disorders in NCWS patients compared to CD and irritable bowel syndrome (IBS)&#xD;
      controls, and 2) the modification of such disorders in NCWS patients after a gluten&#xD;
      (wheat)-free diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last few years, a new clinical entity has emerged which includes patients who 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), although in a recent article, the investigators suggested the term&#xD;
      &quot;non-celiac wheat sensitivity&quot; (NCWS), because it is not known to date what component of&#xD;
      wheat actually causes the symptoms. Other areas of doubt in NCWS regard its pathogenesis,&#xD;
      while some papers reported intestinal immunologic activation, others linked NCWS to the&#xD;
      dietary short chain carbohydrate (fermentable oligo-di-monosaccharides and polyols, FODMAPs)&#xD;
      load. The investigators recently demonstrated that higher proportions of patients with NCWS&#xD;
      develop autoimmune disorders, are antinuclear antibodies (ANA) positive, and show DQ2/DQ8&#xD;
      haplotypes compared with patients with IBS, supporting an immunologic involvement in NCWS.&#xD;
      The clinical picture of NCWS is characterized by combined gastrointestinal (bloating,&#xD;
      abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal&#xD;
      reflux, aphthous stomatitis) and very different extra-intestinal and systemic manifestations&#xD;
      (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash,&#xD;
      fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Nowadays, there no&#xD;
      data about a possible relationship between gynaecological disorders (i.e. menstrual cycle&#xD;
      alterations, vaginitis, recurrent vulvovaginitis, recurrent cystitis, chronic pelvic pain,&#xD;
      recurrent pregnancy loss, infertility) and food ingestion and food allergy/intolerance.&#xD;
      Therefore, the aims of the present study are to investigate 1) the prevalence and&#xD;
      characteristics of gynaecological disorders in NCWS patients compared to CD and IBS controls,&#xD;
      and 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2001</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gynaecological disorders in NCWS female patients at baseline</measure>
    <time_frame>Up to 200 months</time_frame>
    <description>Prevalence of gynaecological disorders in retrospective and prospective NCWS female patients, compared to retrospective and prospective CD and IBS female patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gynaecological disorders in NCWS female patients after gluten-free diet.</measure>
    <time_frame>Change from baseline at 6 months of gluten-free diet</time_frame>
    <description>Gynaecological disorders evaluation after at least 6 months of gluten-free diet after the NCWS diagnosis, by visual analogic scales, specific questionnaire, and clinical examination, both in retrospective and prospective NCWS female patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pap smear in NCWS female patients after gluten-free diet.</measure>
    <time_frame>Change from baseline at 6 months of gluten-free diet</time_frame>
    <description>PAP smear after at least 6 months of gluten-free diet after the NCWS diagnosis, both in retrospective and prospective NCWS female patients.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Non-celiac Wheat Sensitivity</condition>
  <arm_group>
    <arm_group_label>1. NCWS retrospective patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The clinical charts of NCWS female patients attending the outpatient centers of the Department of Internal Medicine at the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca will be reviewed with a retrospective method. They had all been diagnosed with NCWS between January 2001 and June 2011 and included in a previously published study. These charts included specific sections for associated gynaecological disorders. Incomplete clinical charts will be excluded. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2. CD retrospective control patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of CD female patients had been randomly chosen by a computer-generated method from female patients diagnosed during the same period (2001-2011) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group was asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3. IBS retrospective control patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of IBS female patients had been randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2001-2011) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group was asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4. NCWS prospective patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigators prospectively will survey adult female patients with functional gastroenterological symptoms according to the Rome III criteria, and a suspected diagnosis of NCWS. The patients will be recruited between January 2017 and January 2018 at the same 2 centers. Most of the patients will be referred owing to gastrointestinal and extraintestinal symptoms, the onset of which, they reported, could be related to wheat ingestion. In addition, patients will be asked about the presence and characteristics of gynaecological disorders using an ad hoc questionnaire. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5. CD prospective control patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of CD female patients will be randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2017-2018) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group will be asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6. IBS prospective control patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of IBS female patients will be randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2017-2018) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group will be asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gluten free diet</intervention_name>
    <description>The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.</description>
    <arm_group_label>1. NCWS retrospective patients</arm_group_label>
    <arm_group_label>2. CD retrospective control patients</arm_group_label>
    <arm_group_label>3. IBS retrospective control patients</arm_group_label>
    <arm_group_label>4. NCWS prospective patients</arm_group_label>
    <arm_group_label>5. CD prospective control patients</arm_group_label>
    <arm_group_label>6. IBS prospective control patients</arm_group_label>
  </intervention>
  <eligibility>
    <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;
        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;
        For NCWS diagnosis it will be evaluated the following exclusion criteria:&#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>Female</gender>
    <minimum_age>15 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>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>
  <results_reference>
    <citation>Mansueto P, D'Alcamo A, Seidita A, Carroccio A. Food allergy in irritable bowel syndrome: The case of non-celiac wheat sensitivity. World J Gastroenterol. 2015 Jun 21;21(23):7089-109. doi: 10.3748/wjg.v21.i23.7089.</citation>
    <PMID>26109796</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. 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, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.</citation>
    <PMID>24169272</PMID>
  </results_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>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</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>gynaecological disorders</keyword>
  <keyword>gluten-free diet</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/NCT03027492
org study id: ACPM15
nct id: NCT03027492
lead sponsor: 
has dmc: No
In the last few years, a new clinical entity has emerged which includes patients who consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named
      non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators
      suggested the term "non-celiac wheat sensitivity" (NCWS), because it is not known to date
      what component of wheat actually causes the symptoms. 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 very
      different extra-intestinal and systemic manifestations (headache, depression, anxiety, 'foggy
      mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm
      numbness, and anemia). Nowadays, there no data about a possible relationship between
      gynaecological disorders and food ingestion and food allergy/intolerance. Therefore, the aims
      of the present study are to investigate 1) the prevalence and characteristics of
      gynaecological disorders in NCWS patients compared to CD and irritable bowel syndrome (IBS)
      controls, and 2) the modification of such disorders in NCWS patients after a gluten
      (wheat)-free diet.
In the last few years, a new clinical entity has emerged which includes patients who 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), although in a recent article, the investigators suggested the term
      "non-celiac wheat sensitivity" (NCWS), because it is not known to date what component of
      wheat actually causes the symptoms. Other areas of doubt in NCWS regard its pathogenesis,
      while some papers reported intestinal immunologic activation, others linked NCWS to the
      dietary short chain carbohydrate (fermentable oligo-di-monosaccharides and polyols, FODMAPs)
      load. The investigators recently demonstrated that higher proportions of patients with NCWS
      develop autoimmune disorders, are antinuclear antibodies (ANA) positive, and show DQ2/DQ8
      haplotypes compared with patients with IBS, supporting an immunologic involvement in NCWS.
      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 very different extra-intestinal and systemic manifestations
      (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash,
      fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Nowadays, there no
      data about a possible relationship between gynaecological disorders (i.e. menstrual cycle
      alterations, vaginitis, recurrent vulvovaginitis, recurrent cystitis, chronic pelvic pain,
      recurrent pregnancy loss, infertility) and food ingestion and food allergy/intolerance.
      Therefore, the aims of the present study are to investigate 1) the prevalence and
      characteristics of gynaecological disorders in NCWS patients compared to CD and IBS controls,
      and 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Gynaecological disorders in NCWS female patients at baseline
time frame: Up to 200 months
description: Prevalence of gynaecological disorders in retrospective and prospective NCWS female patients, compared to retrospective and prospective CD and IBS female patients.
measure: Gynaecological disorders in NCWS female patients after gluten-free diet.
time frame: Change from baseline at 6 months of gluten-free diet
description: Gynaecological disorders evaluation after at least 6 months of gluten-free diet after the NCWS diagnosis, by visual analogic scales, specific questionnaire, and clinical examination, both in retrospective and prospective NCWS female patients.
measure: Pap smear in NCWS female patients after gluten-free diet.
time frame: Change from baseline at 6 months of gluten-free diet
description: PAP smear after at least 6 months of gluten-free diet after the NCWS diagnosis, both in retrospective and prospective NCWS female patients.
arm group label: 1. NCWS retrospective patients
arm group type: Active Comparator
description: The clinical charts of NCWS female patients attending the outpatient centers of the Department of Internal Medicine at the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca will be reviewed with a retrospective method. They had all been diagnosed with NCWS between January 2001 and June 2011 and included in a previously published study. These charts included specific sections for associated gynaecological disorders. Incomplete clinical charts will be excluded. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
arm group label: 2. CD retrospective control patients
arm group type: Active Comparator
description: To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of CD female patients had been randomly chosen by a computer-generated method from female patients diagnosed during the same period (2001-2011) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group was asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
arm group label: 3. IBS retrospective control patients
arm group type: Active Comparator
description: To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of IBS female patients had been randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2001-2011) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group was asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
arm group label: 4. NCWS prospective patients
arm group type: Active Comparator
description: The investigators prospectively will survey adult female patients with functional gastroenterological symptoms according to the Rome III criteria, and a suspected diagnosis of NCWS. The patients will be recruited between January 2017 and January 2018 at the same 2 centers. Most of the patients will be referred owing to gastrointestinal and extraintestinal symptoms, the onset of which, they reported, could be related to wheat ingestion. In addition, patients will be asked about the presence and characteristics of gynaecological disorders using an ad hoc questionnaire. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
arm group label: 5. CD prospective control patients
arm group type: Active Comparator
description: To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of CD female patients will be randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2017-2018) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group will be asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
arm group label: 6. IBS prospective control patients
arm group type: Active Comparator
description: To compare the presence and characteristics of gynaecological disorders in NCWS female patients, a control group of IBS female patients will be randomly chosen by a computer-generated method from female subjects diagnosed during the same period (2017-2018) and age- (+2 years) matched with the NCWS female patients. Similar to NCWS patients, also this control group will be asked for gynaecological disorders and the answers reported in the patients clinical charts. All the patients will be evaluated at baseline (i.e. at diagnosis) and after at least a 6-months period of gluten-free diet.
intervention type: Other
intervention name: Gluten free diet
description: The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
arm group label: 1. NCWS retrospective patients
arm group label: 2. CD retrospective control patients
arm group label: 3. IBS retrospective control patients
arm group label: 4. NCWS prospective patients
arm group label: 5. CD prospective control patients
arm group label: 6. IBS prospective control patients
criteria: 
gender: Female
minimum age: 15 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: 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
citation: Mansueto P, D'Alcamo A, Seidita A, Carroccio A. Food allergy in irritable bowel syndrome: The case of non-celiac wheat sensitivity. World J Gastroenterol. 2015 Jun 21;21(23):7089-109. doi: 10.3748/wjg.v21.i23.7089.
PMID: 26109796
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. 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, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.
PMID: 24169272
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
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: MD
mesh term: Hypersensitivity
sharing ipd: No