<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/NCT03758144</url>
  </required_header>
  <id_info>
    <org_study_id>4493</org_study_id>
    <nct_id>NCT03758144</nct_id>
  </id_info>
  <brief_title>Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes</brief_title>
  <official_title>Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal&#xD;
      disorders including metabolic syndrome, cardiovascular disease, and obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut&#xD;
      microbiota, which are a critical regulator of host metabolism and immune responses. gut&#xD;
      microbiota interacts with host signaling pathways, leading to modulation of the endocrine&#xD;
      system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids,&#xD;
      have been significantly associated with liability to diabetes. patients with positive fecal&#xD;
      short-chain fatty acids will be given rifaximin&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in glycemic control</measure>
    <time_frame>3 months</time_frame>
    <description>Fasting blood sugar, post-prandial blood sugar (mg/dl)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptom questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>symptomatic improvement in Dyspepsia, distension, abdominal pain</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change in weight</measure>
    <time_frame>6 months</time_frame>
    <description>Weight loss in kilograms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifaximin 200 MG</intervention_name>
    <description>patients with type 2 diabetes and gut dysbiosis will be given rifaximin</description>
    <arm_group_label>study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diabetes with gut dysbiosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent antibiotic use&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  diabetogenic drugs&#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>Amr hanafy, MD</last_name>
    <phone>+201100061861</phone>
    <email>dr_amr_hanafy@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <state>Sharkia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amr Hanafy, md</last_name>
      <phone>+201100061861</phone>
      <email>dr_amr_hanafy@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Amr Shaaban Hanafy</investigator_full_name>
    <investigator_title>Assistant professor of medicine</investigator_title>
  </responsible_party>
  <keyword>gut dysbiosis</keyword>
  <keyword>rifaximin</keyword>
  <keyword>insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifaximin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>personal contact</ipd_description>
  </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/NCT03758144
org study id: 4493
nct id: NCT03758144
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal
      disorders including metabolic syndrome, cardiovascular disease, and obesity.
Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut
      microbiota, which are a critical regulator of host metabolism and immune responses. gut
      microbiota interacts with host signaling pathways, leading to modulation of the endocrine
      system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids,
      have been significantly associated with liability to diabetes. patients with positive fecal
      short-chain fatty acids will be given rifaximin
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in glycemic control
time frame: 3 months
description: Fasting blood sugar, post-prandial blood sugar (mg/dl)
measure: Gastrointestinal symptom questionnaire
time frame: 1 month
description: symptomatic improvement in Dyspepsia, distension, abdominal pain
measure: change in weight
time frame: 6 months
description: Weight loss in kilograms
arm group label: study
arm group type: Active Comparator
arm group label: CONTROL GROUP
arm group type: No Intervention
intervention type: Drug
intervention name: Rifaximin 200 MG
description: patients with type 2 diabetes and gut dysbiosis will be given rifaximin
arm group label: study
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Amr hanafy, MD
phone: +201100061861
email: dr_amr_hanafy@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Amr Shaaban Hanafy
investigator title: Assistant professor of medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Resistance
mesh term: Rifaximin
sharing ipd: No
ipd description: personal contact