<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/NCT03268720</url>
  </required_header>
  <id_info>
    <org_study_id>Glutensensitivity</org_study_id>
    <nct_id>NCT03268720</nct_id>
  </id_info>
  <brief_title>Influence of the Immunosystem in Non-celiac Glutensensitivity</brief_title>
  <acronym>NCGS</acronym>
  <official_title>Influence of the Immunosystem in Non-celiac Glutensensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and&#xD;
      extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly&#xD;
      correlate with ingestion of gluten-containing cereals and disappear quickly under elimination&#xD;
      diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine&#xD;
      the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and&#xD;
      a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being.&#xD;
      Furthermore, the influence of the diets on the microbiome will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac&#xD;
      disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and&#xD;
      gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat&#xD;
      specific IgE are done.&#xD;
&#xD;
      After exclusion of celiac disease and wheat allergy patients are considered as patients with&#xD;
      NCGS.&#xD;
&#xD;
      Patients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed&#xD;
      by a 5 day washout and subsequent two week gluten-free diet.&#xD;
&#xD;
      At the beginning and the end of each diet the participants fill in questionnaires concerning&#xD;
      Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB),&#xD;
      gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart).&#xD;
      Furthermore, stool samples are selected at each time point to determine the microbial&#xD;
      pattern.&#xD;
&#xD;
      NCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of clinical symptomatics</measure>
    <time_frame>2 weeks</time_frame>
    <description>Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of psychological symptoms</measure>
    <time_frame>2 weeks</time_frame>
    <description>Improvement of well-being by questionnaire psychological General well-being index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol</measure>
    <time_frame>2 weeks</time_frame>
    <description>Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraepithelial lymphocytes</measure>
    <time_frame>4 weeks</time_frame>
    <description>numbers of intraepithelial lymphocytes in duodenal mucosa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goblet cells</measure>
    <time_frame>4 weeks</time_frame>
    <description>numbers of Goblet cells in duodenal mucosa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microbiome</measure>
    <time_frame>2 weeks</time_frame>
    <description>Analysis of microbiota pattern</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Gluten Sensitivity</condition>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FODMAP low diet gluten-free diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCGS patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FODMAP low diet gluten-free diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FODMAP low diet</intervention_name>
    <description>2 week FODMAP low diet</description>
    <arm_group_label>NCGS patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>gluten-free diet</intervention_name>
    <description>2 week gluten-free diet</description>
    <arm_group_label>NCGS patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy controls&#xD;
&#xD;
          -  patients with glutensensitivity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with glutensensitivity but without celiac disease or wheat allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>yurdagül zopf</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>gluten sensitivity</keyword>
  <keyword>gluten-free diet</keyword>
  <keyword>FODMAP diet</keyword>
  <keyword>microbiome</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/NCT03268720
org study id: Glutensensitivity
nct id: NCT03268720
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and
      extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly
      correlate with ingestion of gluten-containing cereals and disappear quickly under elimination
      diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine
      the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and
      a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being.
      Furthermore, the influence of the diets on the microbiome will be analyzed.
Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac
      disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and
      gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat
      specific IgE are done.

      After exclusion of celiac disease and wheat allergy patients are considered as patients with
      NCGS.

      Patients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed
      by a 5 day washout and subsequent two week gluten-free diet.

      At the beginning and the end of each diet the participants fill in questionnaires concerning
      Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB),
      gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart).
      Furthermore, stool samples are selected at each time point to determine the microbial
      pattern.

      NCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the
      study.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.
primary purpose: Basic Science
masking: None (Open Label)
measure: Determination of clinical symptomatics
time frame: 2 weeks
description: Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score
measure: Determination of psychological symptoms
time frame: 2 weeks
description: Improvement of well-being by questionnaire psychological General well-being index
measure: Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol
time frame: 2 weeks
description: Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein.
measure: Intraepithelial lymphocytes
time frame: 4 weeks
description: numbers of intraepithelial lymphocytes in duodenal mucosa
measure: Goblet cells
time frame: 4 weeks
description: numbers of Goblet cells in duodenal mucosa
measure: microbiome
time frame: 2 weeks
description: Analysis of microbiota pattern
arm group label: healthy controls
arm group type: Other
description: FODMAP low diet gluten-free diet
arm group label: NCGS patients
arm group type: Other
description: FODMAP low diet gluten-free diet
intervention type: Other
intervention name: FODMAP low diet
description: 2 week FODMAP low diet
arm group label: NCGS patients
arm group label: healthy controls
intervention type: Other
intervention name: gluten-free diet
description: 2 week gluten-free diet
arm group label: NCGS patients
arm group label: healthy controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: yurdagül zopf
investigator title: Prof. Dr.
mesh term: Hypersensitivity
sharing ipd: No