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/NCT05988528</url>
    </required_header>
    <id_info>
      <org_study_id>8/2023</org_study_id>
      <nct_id>NCT05988528</nct_id>
    </id_info>
    <brief_title>Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis</brief_title>
    <official_title>Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis</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>
        Ulcerative colitis (UC) is one of the most common types of chronic and non-specific&#xD;
        inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and&#xD;
        diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the&#xD;
        colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency,&#xD;
        and tenesmus, which extremely alters their quality of life.&#xD;
  &#xD;
        Although the precise pathological mechanism of UC remains unclear, several studies have been&#xD;
        outlined many factors that could involve in the pathogenesis of UC, including, but not&#xD;
        limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant&#xD;
        status, dysregulation of the immune response, alteration of gut microbiota, and delaying&#xD;
        epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune&#xD;
        response are the key events during colitis development&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 2023</start_date>
    <completion_date type="Anticipated">November 20, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2027</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, Care Provider)</masking>
      <masking_description>double blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The primary endpoint is the improvement in health-related quality of life</measure>
      <time_frame>6 months</time_frame>
      <description>The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224</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>Nifuroxazide group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times 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>Nifuroxazide group</arm_group_label>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nifuroxazide</intervention_name>
      <description>Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections</description>
      <arm_group_label>Nifuroxazide 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;
            -  Other inflammatory bowel diseases (CD).&#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 Fenofibrate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</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>Tanta University</name>
        <address>
          <city>Tanta</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wala A Negm, Dr</last_name>
        <email>walaa.negm@pharm.tanta.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</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>Nifuroxazide</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/NCT05988528
  org study id: 8/2023
  nct id: NCT05988528
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Ulcerative colitis (UC) is one of the most common types of chronic and non-specific
        inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and
        diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the
        colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency,
        and tenesmus, which extremely alters their quality of life.
  
        Although the precise pathological mechanism of UC remains unclear, several studies have been
        outlined many factors that could involve in the pathogenesis of UC, including, but not
        limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant
        status, dysregulation of the immune response, alteration of gut microbiota, and delaying
        epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune
        response are the key events during colitis development
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: double blinded
  measure: The primary endpoint is the improvement in health-related quality of life
  time frame: 6 months
  description: The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224
  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: Nifuroxazide group
  arm group type: Active Comparator
  description: Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times 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: Nifuroxazide group
  arm group label: control group
  intervention type: Drug
  intervention name: Nifuroxazide
  description: Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections
  arm group label: Nifuroxazide group
  criteria: 
  gender: All
  minimum age: 18 Years
  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: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Inflammatory Bowel Diseases
  mesh term: Nifuroxazide
  mesh term: Mesalamine