<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/NCT04466449</url>
  </required_header>
  <id_info>
    <org_study_id>Entamoeba spp. Identification</org_study_id>
    <nct_id>NCT04466449</nct_id>
  </id_info>
  <brief_title>Identification of Entamoeba Spp. in Assuit Governorate Hospitals.</brief_title>
  <official_title>Different Methods for Detection and Identification of Entamoeba Species in Assuit Governorate Hospitals.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      1. Determination the prevalence of Entamoeba histolytica infections among patients at&#xD;
           Assiut University Hospitals presented with diarrhea/dysentery.&#xD;
&#xD;
        2. Evaluatation the role of different cultures in diagnosing Entamoeba .&#xD;
&#xD;
        3. Molecularly differentiation between Entamoeba species to monitor the true prevalence of&#xD;
           E.histolytica .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Entamoeba histolytica is a common pathogenic protozoan widely distributed throughout the&#xD;
      world (10% of the world's population), with 50,000-100,000 deaths reported annually(1) .It is&#xD;
      a health problem both in Egypt and worldwide (2) The disease is more prevalent in densely&#xD;
      populated areas with poor hygiene requirements and lacking sanitary water supply, especially&#xD;
      in rural areas(3). It causes many digestive complications including diarrhea , and fever(2).&#xD;
      it transmits through bloodstream forming abscesses in the brain, eye, liver and other vital&#xD;
      organs and tissues or even lead to death in some cases . Some individuals have no symptom of&#xD;
      the disease but transmit the infection to others(4) It is well- established that E.&#xD;
      histolytica leads to invasive disease in humans. Although both E. dispar and E. moshkovskii&#xD;
      are still considered to be non pathogenic and free-living amoebas, respectively, some reports&#xD;
      suggest their potential role in provoking disease in humans (5) Cysts of E.dispar ,&#xD;
      E.moshkovskii and E.hartmanni can be confused with E.histolytica. cysts in the&#xD;
      parasitological examination(6) The molecular assays, is preferable as it detects E.&#xD;
      histolytica , differentiates it from other species and monitors its true prevalence for&#xD;
      better treatment and effective control (2)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">September 2022</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery</measure>
    <time_frame>2022</time_frame>
    <description>Different Methods for Detection and Identification of Entamoeba species in Assuit Governorate.</description>
  </primary_outcome>
  <enrollment type="Anticipated">138</enrollment>
  <condition>Entamoeba Spp. Identification</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>stool sample</intervention_name>
    <description>A stool sample will be collected from each patient for diagnosis of Entamoeba</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients of different age groups with diarrhea/dysentery attending the&#xD;
        outpatient clinics at Assiut University Hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  : Male and female patients of different age groups with diarrhea/dysentery attending&#xD;
             the outpatient clinics at Assiut University Hospitals .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Youstina Talaat</last_name>
    <phone>01225530091</phone>
    <email>youstinatalaat63@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abeer Lsayed Mahmoud</last_name>
    <phone>01028241777</phone>
    <email>abeerwns@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Youstina Talaat</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>youstina Talaat, demonestrator</last_name>
      <phone>01225530091</phone>
      <email>youstinatalaat@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Youstina Talaat Basaly</investigator_full_name>
    <investigator_title>YTalaatBasaly</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04466449
org study id: Entamoeba spp. Identification
nct id: NCT04466449
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. Determination the prevalence of Entamoeba histolytica infections among patients at
           Assiut University Hospitals presented with diarrhea/dysentery.

        2. Evaluatation the role of different cultures in diagnosing Entamoeba .

        3. Molecularly differentiation between Entamoeba species to monitor the true prevalence of
           E.histolytica .
Entamoeba histolytica is a common pathogenic protozoan widely distributed throughout the
      world (10% of the world's population), with 50,000-100,000 deaths reported annually(1) .It is
      a health problem both in Egypt and worldwide (2) The disease is more prevalent in densely
      populated areas with poor hygiene requirements and lacking sanitary water supply, especially
      in rural areas(3). It causes many digestive complications including diarrhea , and fever(2).
      it transmits through bloodstream forming abscesses in the brain, eye, liver and other vital
      organs and tissues or even lead to death in some cases . Some individuals have no symptom of
      the disease but transmit the infection to others(4) It is well- established that E.
      histolytica leads to invasive disease in humans. Although both E. dispar and E. moshkovskii
      are still considered to be non pathogenic and free-living amoebas, respectively, some reports
      suggest their potential role in provoking disease in humans (5) Cysts of E.dispar ,
      E.moshkovskii and E.hartmanni can be confused with E.histolytica. cysts in the
      parasitological examination(6) The molecular assays, is preferable as it detects E.
      histolytica , differentiates it from other species and monitors its true prevalence for
      better treatment and effective control (2)
observational model: Other
time perspective: Cross-Sectional
measure: Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery
time frame: 2022
description: Different Methods for Detection and Identification of Entamoeba species in Assuit Governorate.
intervention type: Diagnostic Test
intervention name: stool sample
description: A stool sample will be collected from each patient for diagnosis of Entamoeba
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Youstina Talaat
phone: 01225530091
email: youstinatalaat63@gmail.com
last name: Abeer Lsayed Mahmoud
phone: 01028241777
email: abeerwns@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Youstina Talaat Basaly
investigator title: YTalaatBasaly
sharing ipd: Undecided