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Status unknownNCT04759937Updated Oct 12, 2021

Immunochromatography Versus Microscopy for Diagnosis of Entamoeba Histolytica/Dispar Infection.

An observational study in Dysentery Amebic, sponsored by Sohag University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Sex
All
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Study summary

Amoebiasis, an infection by the protozoan parasite Entamoeba histolytica is globally considered as the third leading parasitic cause of human mortality besides malaria and schistosomiasis. It is estimated that E. histolytica may infect half a billion people annually. Moreover, it was estimated that 100,000 patients per year died due to the clinical complications of the disease. Laboratory diagnosis of E. histolytica/dispar is usually achieved by microscopic detection of trophozoites or cysts in stool samples. Microscopy is time consuming and requires an experienced observer to identify the organism. Furthermore, it must be performed on three stool samples to increase sensitivity leading to decreased patient compliance and delay in the final diagnosis. Therefore, a few the commercially available copro-antigen assay have been developed for E. histolytica/dispar diagnosis including the enzyme immunoassay and non-enzymatic immunochromatographic (ICT) assays that do not depend on microscopy skills and increase laboratory efficiency by reducing time and cost.

The aim of the study is:

  1. to evaluate the efficacy of commercially available rapid immunochromatographic Copro-antigen assay (RIDA® QUICK Entamoeba) in comparison with conventional microscopic examination for the diagnosis of E. histolytica /dispar infection.
  2. to estimate the prevalence of E. histolytica /dispar infection in outpatients in Sohag.
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Conditions studied

  • Dysentery Amebic

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Keywords

  • dysentery
  • diarrhea
  • Entamoeba
  • histolytica
  • dispar
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In context

Dysentery

44 studies on the registry are indexed under Dysentery; 6 are open to participants now.

Browse Dysentery studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

samples will be collected from outpatients complaining of dysentery or diarrhea with any age \& sex groups from different locations (cities and village).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients complaining of dysentery or diarrhea with any age \& sex groups.

Exclusion criteria

Exclusion Criteria:

  • Patients taking amoebicidal drugs.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. evaluate the efficacy of immunochromatographic Copro-antigen assay for diagnosis of Entamoeba histolytica/ dispar.

    comparing the sensitivity and specifity with conventional microscopy for diagnosis of Entamoeba histolytica/ dispar infection.

    Time frame: 16 weeks following the startpoint of the study.

Secondary outcomes

  1. detect the prevelance of Entamoeba histolytica/ dispar in Sohag.

    By examining stool samples from 100 patients, the number of cases with Entamoena histolytica/dispar infection is recorded.

    Time frame: 16 weeks following the startpoint of the study.

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided — undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2021 (actual). Primary completion is estimated for Oct 2021, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2021
First posted
Feb 18, 2021
StartActual
Mar 20, 2021
Primary completionEst.
Oct 2021
CompletionEst.
Dec 2021
Last update
Oct 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04759937
Lead sponsor
Sohag University
Responsible party
Khoulood Zakaria Hashem (Demonstrator at medical parasitology department, Faculty of medicine, Sohag University) — Principal investigator
First posted
Feb 18, 2021
Start date
Mar 20, 2021
Primary completion
Oct 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Oct 12, 2021

Study contacts

khoulood Zakaria Hashem
Contact
khoulood.zakaria@med.sohag.edu.eg
01127936972 ext. +20

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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