Chronic DiarrheaNCT05724381
Auramine Phenol Staining Technique for Revealing Different Coccidian Parasites
An observational study of Chronic Diarrhea, run by Sohag University.
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… Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Chronic Diarrhea
- What is being tested?
- auramine phenol staining
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- Child, Adult, Older adult
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)
Who may be able to join
- patients complaining of chronic diarrhea .
Who cannot join
- patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.
Trial locations and contacts
No sites are listed yet.
Khoulood Zakaria Hashem Abd El-Hafez, Assistant Lecturer contact
Shimaa Refaey Mohamed Abd-Elal, Assistant Lecturer contact
About this study
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
Read the 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.
- Conditions
- Chronic Diarrhea
- Being tested
- auramine phenol staining
- Keywords
- coccidian parasites, auramine phenol staining, fluorescence microscopy, modified Ziehl Nelseen, Cryptosporidium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auramine phenol stainingDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of coccidian parasites
number of patients positive for coccidian parasites
Measured: 1 month
Secondary outcomes (1)
auramine phenol staining
accuracy of auramine phenol staining in the detection of coccidian parasites in comparison to light microscopy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiarrheaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khoulood Zakaria Hashem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724381
- Sponsor's protocol ID
- Soh-Med-23-01-25
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auramine Phenol Staining Technique for Revealing Different Coccidian Parasites
- ClinicalTrials.gov ID
- NCT05724381
- Acronym / sponsor ID
- Soh-Med-23-01-25
- Conditions
- Chronic Diarrhea
- Keywords
- coccidian parasites, auramine phenol staining, fluorescence microscopy, modified Ziehl Nelseen, Cryptosporidium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- patients complaining of chronic diarrhea .
Key exclusion criteria (1 listed)
- patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auramine phenol stainingThe 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. | Diagnostic test | – |
Primary outcome
prevalence of coccidian parasites
Time frame: 1 month
number of patients positive for coccidian parasites
1 secondary outcome
auramine phenol staining
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khoulood Zakaria Hashem Abd El-Hafez, Assistant Lecturer contact
Shimaa Refaey Mohamed Abd-Elal, Assistant Lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diarrhea, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khoulood Zakaria Hashem Abd El-Hafez, Assistant Lecturer (01127936972 ext. +20, Khoulood.zakaria@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of coccidian parasites (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.