NCT05724381

Brief Summary

The increased number of documented human coccidian infections, including Cryptosporidium parvum, Cyclospora cayetanensis, Isospora belli, and Sarcocystis spp., that are often indistinguishable from other forms of community-acquired diarrhea, together with the possibility of treating some of them, suggests a need for proper diagnostic techniques to recover and identify these organisms

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 2, 2023

Last Update Submit

February 2, 2023

Conditions

Keywords

coccidian parasitesauramine phenol stainingfluorescence microscopymodified Ziehl NelseenCryptosporidium

Outcome Measures

Primary Outcomes (1)

  • prevalence of coccidian parasites

    number of patients positive for coccidian parasites

    1 month

Secondary Outcomes (1)

  • auramine phenol staining

    1 month

Interventions

The samples will be divided into 2 parts. The 1st part will be subjected to a direct wet saline smear, iodine smear, and concentration techniques. The 2nd part will be used to perform thin smears of the fecal concentrates and air-dried on 2 different slides. The first slide will be stained with Kinyoun's acid-fast stain and examined with the conventional light microscope and the second will be stained with auramine-phenol stain and examined with the fluorescent microscope.

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients from outpatient clinics in different hospitals in Sohag governorate complaining of diarrhea of any age and sex groups from different locations (cities and villages)

You may qualify if:

  • patients complaining of chronic diarrhea .

You may not qualify if:

  • patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Khoulood Zakaria Hashem Abd El-Hafez, Assistant Lecturer

CONTACT

Shimaa Refaey Mohamed Abd-Elal, Assistant Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of medical parasitology at the Faculty of Medicine

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

February 13, 2023

Record last verified: 2023-02