Auramine Phenol Staining Technique for Revealing Different Coccidian Parasites

February 2, 2023 updated by: Khoulood Zakaria Hashem, Sohag University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Earlier, Cryptosporidium and Cystoisospora were assumed to be the causative agents of acute diarrhea in animals but recently have emerged as one of the leading causes of prolonged lifethreatening diarrhea in immunocompromised patients particularly in those with immune dysfunction like AIDS who may show severe intestinal injury, prolonged diarrhea, extreme weight loss, and generalized wasting. In contrast, healthy individuals commonly present with mild to moderate self-limiting diarrhea during the infective stage, besides asymptomatic infection can also occur.

Detection of coccidian parasites is mostly through microscopic observation using Kinyon's acid-fast stain. Although Sheather sugar flotation may result in increased concentration of the cysts, this method is cumbersome and does not lend itself to convenient incorporation within the routine concentration and staining procedures favored in most clinical laboratories. Any acid-fast stain will be taken up by cyst walls, but the time required to prepare and examine acid-fast stains on all stool samples received for routine parasitology would not be cost-effective unless the prevalence of coccidian parasites was shown to warrant such effort.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability 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)

Description

Inclusion Criteria:

  • patients complaining of chronic diarrhea .

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of coccidian parasites
Time Frame: 1 month
number of patients positive for coccidian parasites
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
auramine phenol staining
Time Frame: 1 month
accuracy of auramine phenol staining in the detection of coccidian parasites in comparison to light microscopy
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-01-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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