Blastocystis InfectionsNCT05724368
Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection
An observational study of Blastocystis Infections, run by Sohag University.
Trial summary
Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%). In developed countries, the prevalence ranges from 0.5% to 23.1%. Read more about this study
- Who is it for?
- Ages 6 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blastocystis Infections
- What is being tested?
- Fecal Calprotectin ELISA kit
- How many people
- 150 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: samples will be collected from outpatients with any age \& sex groups from different locations (cities and villages).
Who may be able to join
- Patients from outpatient clinics, Sohag hospitals.
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.
Shimaa Refaey Mohamed AbdElal, Assistant Lecturer contact
Khoulood Zakaria Hashem Abd-Elhafez, Assistant Lecturer contact
About this study
Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).
In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food .
Read the detailed description
Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).
In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food. The pathogenicity of Blastocystis is controversial because most patients carrying this parasite are asymptomatic. Several studies have considered Blastocystis sp. as a commensal micro-organism, while other results have showed the pathogenicity of the parasite.
Calprotectin (CP), a calcium-binding protein, comprises 60% of cytosolic protein found in neutrophils. Fecal calprotectin (F-CP) concentration is an indicator of neutrophil migration into the intestinal lumen and is associated with intestinal inflammation.
- Conditions
- Blastocystis Infections
- Being tested
- Fecal Calprotectin ELISA kit
- Keywords
- Blastocystis, Calprotectin
- Medical subject headings
- Blastocystis Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Calprotectin ELISA kitDiagnostic test
- Routine stool examination will be done in addition to certain concentration, staining and culture techniques.
- Fecal calprotectin will be evaluated using ELISA kits according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with gastrointestinal symptoms and positive only for Blastocystis. Receives: Diagnostic Test: Fecal Calprotectin ELISA kit | |
| Group 2 | Patients with gastrointestinal symptoms and Blastocystis free. Receives: Diagnostic Test: Fecal Calprotectin ELISA kit | |
| Group 3 | Healthy volunteers with neither gastrointestinal symptoms nor parasitological infections. Receives: Diagnostic Test: Fecal Calprotectin ELISA kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of fecal calprotectin
Evaluation of fecal calprotectin inflammation levels of Blastocystis hominis in patients with gastrointestinal troubles as compared to patients with gastrointestinal troubles but without Blastocystis hominis
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 Blastocystis InfectionsStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Refaey Mohamed Abd-Elal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724368
- Sponsor's protocol ID
- Soh-Med-23-01-24
- 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
- Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection
- ClinicalTrials.gov ID
- NCT05724368
- Acronym / sponsor ID
- Soh-Med-23-01-24
- Conditions
- Blastocystis Infections
- Keywords
- Blastocystis, Calprotectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 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.
Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).
In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food .
Detailed description
Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).
In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food. The pathogenicity of Blastocystis is controversial because most patients carrying this parasite are asymptomatic. Several studies have considered Blastocystis sp. as a commensal micro-organism, while other results have showed the pathogenicity of the parasite.
Calprotectin (CP), a calcium-binding protein, comprises 60% of cytosolic protein found in neutrophils. Fecal calprotectin (F-CP) concentration is an indicator of neutrophil migration into the intestinal lumen and is associated with intestinal inflammation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Fecal Calprotectin ELISA kitPatients with gastrointestinal symptoms and positive only for Blastocystis. |
| Group 2 | – | Diagnostic Test: Fecal Calprotectin ELISA kitPatients with gastrointestinal symptoms and Blastocystis free. |
| Group 3 | – | Diagnostic Test: Fecal Calprotectin ELISA kitHealthy volunteers with neither gastrointestinal symptoms nor parasitological infections. |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- samples will be collected from outpatients with any age \& sex groups from different locations (cities and villages).
Key inclusion criteria (1 listed)
- Patients from outpatient clinics, Sohag hospitals.
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 |
|---|---|---|
| Fecal Calprotectin ELISA kit* Routine stool examination will be done in addition to certain concentration, staining and culture techniques. * Fecal calprotectin will be evaluated using ELISA kits according to the manufacturer's instructions. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
level of fecal calprotectin
Time frame: 1 month
Evaluation of fecal calprotectin inflammation levels of Blastocystis hominis in patients with gastrointestinal troubles as compared to patients with gastrointestinal troubles but without Blastocystis hominis
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
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.
Shimaa Refaey Mohamed AbdElal, Assistant Lecturer contact
Khoulood Zakaria Hashem Abd-Elhafez, Assistant Lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Blastocystis Infections, 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 Shimaa Refaey Mohamed AbdElal, Assistant Lecturer (01144981097 ext. +20, Shimaa.refaee@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of fecal calprotectin (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.