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/NCT05986136</url>
    </required_header>
    <id_info>
      <org_study_id>Tanta 1234</org_study_id>
      <nct_id>NCT05986136</nct_id>
    </id_info>
    <brief_title>Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease</brief_title>
    <official_title>Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mostafa Bahaa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory&#xD;
        conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The&#xD;
        common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and&#xD;
        chronic fatigue; events that may culminate in life-threatening complications. The&#xD;
        pathogenesis of IBD has been characterized as complex/multi-factorial that includes&#xD;
        disruption of intestinal epithelial barrier with consequent translocation of commensal&#xD;
        microbial products as the prime event that instigates severe immune responses and intestinal&#xD;
        inflammation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>double-blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The primary endpoint is the change in mayo score</measure>
      <time_frame>6 months</time_frame>
      <description>The Mayo score is one of the most commonly used disease activity indices in placebo-controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dapagliflozin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mesalamine</intervention_name>
      <description>Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis</description>
      <arm_group_label>Dapagliflozin group</arm_group_label>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dapagliflozin 10mg Tab</intervention_name>
      <description>Dapagliflozin has emerged as a selective SGLT2 inhibitor for the management of type-2 diabetes mellitus with minimal risk of hypoglycemia and it exerts diuretic-like actions and lowering of blood pressure, thereby, reducing the risk of hospitalization in type-2 diabetic patients with co-existing heart failure</description>
      <arm_group_label>Dapagliflozin group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Both male and female will be&#xD;
  &#xD;
            -  Mild and moderate UC patients diagnosed and confirmed by endoscope&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Breast feeding&#xD;
  &#xD;
            -  Significant liver and kidney function abnormalities&#xD;
  &#xD;
            -  Colorectal cancer patients&#xD;
  &#xD;
            -  Patients with severe UC&#xD;
  &#xD;
            -  Patients taking rectal or systemic steroids&#xD;
  &#xD;
            -  Patients taking immunosuppressives or biological therapies&#xD;
  &#xD;
            -  Addiction to alcohol and / or drugs&#xD;
  &#xD;
            -  Known allergy to the dapagliflozin&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Months</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mostafa Bahaa, PhD</last_name>
      <phone>0201025538337</phone>
      <email>mbahaa@horus.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine, Mansoura University</name>
        <address>
          <city>Mansoura</city>
          <zip>7650001</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mostafa Bahaa, PhD</last_name>
        <phone>0201025538337</phone>
        <email>mbahaa@horus.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Mostafa Bahaa</investigator_full_name>
      <investigator_title>Teaching assisstant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dapagliflozin</mesh_term>
      <mesh_term>Mesalamine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05986136
  org study id: Tanta 1234
  nct id: NCT05986136
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory
        conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The
        common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and
        chronic fatigue; events that may culminate in life-threatening complications. The
        pathogenesis of IBD has been characterized as complex/multi-factorial that includes
        disruption of intestinal epithelial barrier with consequent translocation of commensal
        microbial products as the prime event that instigates severe immune responses and intestinal
        inflammation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: double-blinded
  measure: The primary endpoint is the change in mayo score
  time frame: 6 months
  description: The Mayo score is one of the most commonly used disease activity indices in placebo-controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance
  arm group label: control group
  arm group type: Active Comparator
  description: Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
  arm group label: Dapagliflozin group
  arm group type: Active Comparator
  description: Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months
  intervention type: Drug
  intervention name: Mesalamine
  description: Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis
  arm group label: Dapagliflozin group
  arm group label: control group
  intervention type: Drug
  intervention name: Dapagliflozin 10mg Tab
  description: Dapagliflozin has emerged as a selective SGLT2 inhibitor for the management of type-2 diabetes mellitus with minimal risk of hypoglycemia and it exerts diuretic-like actions and lowering of blood pressure, thereby, reducing the risk of hospitalization in type-2 diabetic patients with co-existing heart failure
  arm group label: Dapagliflozin group
  criteria: 
  gender: All
  minimum age: 18 Months
  maximum age: 60 Years
  healthy volunteers: No
  last name: Mostafa Bahaa, PhD
  phone: 0201025538337
  email: mbahaa@horus.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tanta University
  investigator full name: Mostafa Bahaa
  investigator title: Teaching assisstant
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  mesh term: Dapagliflozin
  mesh term: Mesalamine