<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/NCT03269305</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU71515</org_study_id>
    <nct_id>NCT03269305</nct_id>
  </id_info>
  <brief_title>An Audit on Management of Chronic Diarrhea</brief_title>
  <acronym>AAOMOCD</acronym>
  <official_title>An Audit on Management of Chronic Diarrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gehad Adel Mohammed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut 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>
      The study is to assess whether the staff in gastroenterology unit are sticking to the agreed&#xD;
      up on unit's protocol in management of chronic diarrhea over the period of one year(september&#xD;
      2017-september 2018)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      chronic diarrhea is defined as having loose or watery stools more than three times&#xD;
      aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some&#xD;
      cases chronic diarrhea is the result of intestinal infection that persists longer than&#xD;
      expected. In other cases chronic diarrhea is apart of a systemic illness.&#xD;
&#xD;
      Etiology:&#xD;
&#xD;
        1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after&#xD;
           acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a&#xD;
           cause.&#xD;
&#xD;
        2. infectious causes:enteric infection is an important cause.Associated conditions may be&#xD;
           T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging&#xD;
           or acquiring another infection.Viral infection like Rota virus,parasites as&#xD;
           E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.&#xD;
&#xD;
        3. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno&#xD;
           compromised patients.&#xD;
&#xD;
        4. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory&#xD;
           bowel disease,all of which may cause chronic diarrhea that is often associated with&#xD;
           abdominal pain with or without elevated levels of inflammatory markers.&#xD;
&#xD;
        5. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually&#xD;
           fatty in nature and bulky in amount.&#xD;
&#xD;
      Good management of chronic diarrhea must include investigations and treatment.A protocol must&#xD;
      be followed accurately therefore.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon&#xD;
      unit's protocol in management of chronic diarrhea over the period of one year (September&#xD;
      2017-September 2018).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>proper management of chronic diarrhea</measure>
    <time_frame>september 2017-september 2018</time_frame>
    <description>start accurate treatment of chronic diarrhea by reaching a definitive cause of each case .&#xD;
decrease the incidence of undiagnosed cases of chronic diarrhea</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Diarrhea</condition>
  <eligibility>
    <study_pop>
      <textblock>
        an audit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age group from 2 months to 18 years&#xD;
&#xD;
          -  cases with diarrhea lasts 2 weeks or more&#xD;
&#xD;
          -  Genetically free&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age group from 0-2 months&#xD;
&#xD;
          -  age group above 18 years&#xD;
&#xD;
          -  cases with diarrhea less than 2 weeks&#xD;
&#xD;
          -  Gentic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faisal Alkhateeb, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gehad</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Gehad Adel Mohammed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <!-- 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/NCT03269305
org study id: AssiutU71515
nct id: NCT03269305
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to assess whether the staff in gastroenterology unit are sticking to the agreed
      up on unit's protocol in management of chronic diarrhea over the period of one year(september
      2017-september 2018)
chronic diarrhea is defined as having loose or watery stools more than three times
      aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some
      cases chronic diarrhea is the result of intestinal infection that persists longer than
      expected. In other cases chronic diarrhea is apart of a systemic illness.

      Etiology:

        1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after
           acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a
           cause.

        2. infectious causes:enteric infection is an important cause.Associated conditions may be
           T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging
           or acquiring another infection.Viral infection like Rota virus,parasites as
           E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.

        3. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno
           compromised patients.

        4. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory
           bowel disease,all of which may cause chronic diarrhea that is often associated with
           abdominal pain with or without elevated levels of inflammatory markers.

        5. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually
           fatty in nature and bulky in amount.

      Good management of chronic diarrhea must include investigations and treatment.A protocol must
      be followed accurately therefore.

      Methodology:

      measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon
      unit's protocol in management of chronic diarrhea over the period of one year (September
      2017-September 2018).
observational model: Other
time perspective: Prospective
measure: proper management of chronic diarrhea
time frame: september 2017-september 2018
description: start accurate treatment of chronic diarrhea by reaching a definitive cause of each case .
decrease the incidence of undiagnosed cases of chronic diarrhea
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Months
maximum age: 18 Years
healthy volunteers: No
last name: Faisal Alkhateeb, Phd
role: Study Director
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Gehad Adel Mohammed
investigator title: principal investigator
mesh term: Diarrhea