xml: <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/NCT06026449</url>
    </required_header>
    <id_info>
      <org_study_id>NU22-06-00269</org_study_id>
      <nct_id>NCT06026449</nct_id>
    </id_info>
    <brief_title>Gluten-free Diet in PSC and IBD</brief_title>
    <official_title>Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute for Clinical and Experimental Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Czech Academy of Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institute for Clinical and Experimental Medicine</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>
        Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which&#xD;
        represents one of the most frequent indications for orthotopic liver transplantation (OLTx)&#xD;
        in developed countries. There are several lines of evidence that dietary gluten/gliadin&#xD;
        displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the&#xD;
        protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes,&#xD;
        irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This&#xD;
        study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective&#xD;
        self-controlled mono-centric intervention study.&#xD;
  &#xD;
        Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal&#xD;
        inflammation in PSC and UC patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective, self-controlled pilot clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Decrease of laboratory markers of cholestasis</measure>
      <time_frame>6-12 months</time_frame>
      <description>Change of alkaline phosphatase &gt; 25% or normalisation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes of intestinal microbiome composition.</measure>
      <time_frame>6-12 months</time_frame>
      <description>16S-rRNA sequencing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes of morphological signs of intestinal inflammation</measure>
      <time_frame>6-12 months</time_frame>
      <description>Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of quality of life and symptoms of ulcerative colitis.</measure>
      <time_frame>6-12 months</time_frame>
      <description>UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of quality of life and symptoms of primary sclerosing cholangitis</measure>
      <time_frame>6-12 months</time_frame>
      <description>PSC quality of life questionnaire (PSC PRO)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of histopathological signs of intestinal inflammation</measure>
      <time_frame>6-12 months</time_frame>
      <description>Nancy histological index (Grade 0 - no histological significant disease; Grade 1 - chronic inflammatory infiltrate with no acute inflammatory infiltrate; Grade 2 - Mildly active disease, Grade 3 - Moderately active disease; Grade 4 - Severly active disease)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline of liver stiffness.</measure>
      <time_frame>6-12 months</time_frame>
      <description>Shear-wave elastography (F0-F4)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Primary Sclerosing Cholangitis</condition>
    <condition>Ulcerative Colitis</condition>
    <condition>Biliary Tract Diseases</condition>
    <condition>Biliary Disease Tract</condition>
    <condition>Intestinal Disease</condition>
    <arm_group>
      <arm_group_label>Primary sclerosing cholangitis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Ulcerative Colitis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Gluten-free diet</intervention_name>
      <description>After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months</description>
      <arm_group_label>Primary sclerosing cholangitis</arm_group_label>
      <arm_group_label>Ulcerative Colitis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (for PSC group):&#xD;
  &#xD;
            -  Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or&#xD;
               ERCP)&#xD;
  &#xD;
            -  Age 18 - 65 years&#xD;
  &#xD;
            -  ALP 1,5x higher than ULN&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria (for PSC group):&#xD;
  &#xD;
            -  Patients on gluten-free diet&#xD;
  &#xD;
            -  Patients with coeliac disease or wheat allergy&#xD;
  &#xD;
            -  Liver transplant recipients&#xD;
  &#xD;
            -  PSC/AIH overlap syndrome&#xD;
  &#xD;
            -  Other causes of liver disease&#xD;
  &#xD;
            -  Radiologic or clinical signs of decompensated liver cirrhosis&#xD;
  &#xD;
            -  Advanced liver cirrhosis (MELD score ˃ 15)&#xD;
  &#xD;
            -  Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months&#xD;
  &#xD;
            -  Use of antibiotics in past 3 months&#xD;
  &#xD;
            -  History of malignancy&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Not signed informed consent&#xD;
  &#xD;
          Inclusion criteria (for UC group):&#xD;
  &#xD;
            -  Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings&#xD;
  &#xD;
            -  Extension of affected colon &gt; 15cm&#xD;
  &#xD;
            -  Mayo score 0-4&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion criteria (for UC group):&#xD;
  &#xD;
            -  CMV, Clostridium difficile enterocolitis in past 3 months&#xD;
  &#xD;
            -  Use of antibiotics in past 3 months&#xD;
  &#xD;
            -  Patients with coeliac disease or wheat allergy&#xD;
  &#xD;
            -  Patients on gluten-free diet&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Not signed informed consent&#xD;
  &#xD;
            -  Biologic therapy&#xD;
  &#xD;
            -  Methotrexate&#xD;
  &#xD;
            -  Prednison &gt; 10 mg&#xD;
  &#xD;
            -  Not signed informed consent&#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_contact>
      <last_name>Pavel Drastich, Assoc. prof., M.D., Ph.D.</last_name>
      <phone>+420603869913</phone>
      <email>padr@ikem.cz</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of clinical and experimental medicine</name>
        <address>
          <city>Prague</city>
          <zip>14021</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jan Brezina, M.D.</last_name>
        <phone>00420739602520</phone>
        <email>jan.brezina@ikem.cz</email>
      </contact>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institute for Clinical and Experimental Medicine</investigator_affiliation>
      <investigator_full_name>Jan Březina</investigator_full_name>
      <investigator_title>Senior consultant</investigator_title>
    </responsible_party>
    <keyword>Primary sclerosing cholangitis</keyword>
    <keyword>Cholangitis</keyword>
    <keyword>Gluten-free diet</keyword>
    <keyword>Ulcerative Colitis</keyword>
    <keyword>Microbiome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</mesh_term>
      <mesh_term>Cholangitis</mesh_term>
      <mesh_term>Cholangitis, Sclerosing</mesh_term>
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Biliary Tract Diseases</mesh_term>
      <mesh_term>Gallbladder Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026449
  org study id: NU22-06-00269
  nct id: NCT06026449
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which
        represents one of the most frequent indications for orthotopic liver transplantation (OLTx)
        in developed countries. There are several lines of evidence that dietary gluten/gliadin
        displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the
        protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes,
        irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This
        study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective
        self-controlled mono-centric intervention study.
  
        Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal
        inflammation in PSC and UC patients.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, self-controlled pilot clinical trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Decrease of laboratory markers of cholestasis
  time frame: 6-12 months
  description: Change of alkaline phosphatase > 25% or normalisation.
  measure: Changes of intestinal microbiome composition.
  time frame: 6-12 months
  description: 16S-rRNA sequencing
  measure: Changes of morphological signs of intestinal inflammation
  time frame: 6-12 months
  description: Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)
  measure: Improvement of quality of life and symptoms of ulcerative colitis.
  time frame: 6-12 months
  description: UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
  measure: Improvement of quality of life and symptoms of primary sclerosing cholangitis
  time frame: 6-12 months
  description: PSC quality of life questionnaire (PSC PRO)
  measure: Changes of histopathological signs of intestinal inflammation
  time frame: 6-12 months
  description: Nancy histological index (Grade 0 - no histological significant disease; Grade 1 - chronic inflammatory infiltrate with no acute inflammatory infiltrate; Grade 2 - Mildly active disease, Grade 3 - Moderately active disease; Grade 4 - Severly active disease)
  measure: Change from baseline of liver stiffness.
  time frame: 6-12 months
  description: Shear-wave elastography (F0-F4)
  arm group label: Primary sclerosing cholangitis
  arm group type: Experimental
  arm group label: Ulcerative Colitis
  arm group type: Experimental
  intervention type: Dietary Supplement
  intervention name: Gluten-free diet
  description: After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months
  arm group label: Primary sclerosing cholangitis
  arm group label: Ulcerative Colitis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Pavel Drastich, Assoc. prof., M.D., Ph.D.
  phone: +420603869913
  email: padr@ikem.cz
  facility: 
  status: Recruiting
  contact: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: Institute for Clinical and Experimental Medicine
  investigator full name: Jan Březina
  investigator title: Senior consultant
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Cholangitis
  mesh term: Cholangitis, Sclerosing
  mesh term: Intestinal Diseases
  mesh term: Biliary Tract Diseases
  mesh term: Gallbladder Diseases
  sharing ipd: No