Auramine Phenol Staining Technique for Revealing Different Coccidian Parasites

Chronic Diarrhea Clinical Trial

Official title:

Auramine Phenol Staining Technique for Revealing Different Coccidian Parasites

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724381
• Other study ID #: Soh-Med-23-01-25
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2023
• Source: Sohag University
• Contact: Khoulood Zakaria Hashem Abd El-Hafez, Assistant Lecturer
• Phone: 01127936972
• Email: Khoulood.zakaria[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Diarrhea
• Diarrhea

Intervention

Diagnostic Test:
• auramine phenol staining
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of coccidian parasites	number of patients positive for coccidian parasites	1 month
Secondary	auramine phenol staining	accuracy of auramine phenol staining in the detection of coccidian parasites in comparison to light microscopy	1 month