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Identification of Entamoeba Spp. in Assuit Governorate

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ClinicalTrials.gov Identifier: NCT04466449
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Youstina Talaat Basaly, Assiut University

Brief Summary:
  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 .

Condition or disease Intervention/treatment
Entamoeba Spp. Identification Diagnostic Test: stool sample

Detailed Description:
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)

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Study Type : Observational
Estimated Enrollment : 138 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Different Methods for Detection and Identification of Entamoeba Species in Assuit Governorate.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Intervention Details:
  • Diagnostic Test: stool sample
    A stool sample will be collected from each patient for diagnosis of Entamoeba


Primary Outcome Measures :
  1. Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery [ Time Frame: 2022 ]
    Different Methods for Detection and Identification of Entamoeba species in Assuit Governorate.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals
Criteria

Inclusion Criteria:

  • : Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals .

Exclusion Criteria:

  • No exclusion criteria .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466449


Contacts
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Contact: Youstina Talaat 01225530091 youstinatalaat63@gmail.com
Contact: Abeer Lsayed Mahmoud 01028241777 abeerwns@yahoo.com

Sponsors and Collaborators
Assiut University
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Responsible Party: Youstina Talaat Basaly, YTalaatBasaly, Assiut University
ClinicalTrials.gov Identifier: NCT04466449    
Other Study ID Numbers: Entamoeba spp. Identification
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No