Fecal Calprotectin in Intestinal ProtozoaNCT06890455
Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections
An observational study of Fecal Calprotectin in Intestinal Protozoa, run by Sohag University at 1 site in Egypt.
Trial summary
Calprotectin extracted from stool can be detected easily using ELISA. Numerous studies have shown that fecal calprotectin concentrations demonstrate a good correlation with intestinal inflammation This study aims to detect the relationship between fecal calprotectin and Blastocystis hominis and Entamoeba histolytica… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fecal Calprotectin in Intestinal Protozoa
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Feb 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 120 fecal samples will be collected as the following: * 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica. * 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection. * 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).
Who may be able to join
- 120 fecal samples will be collected as the following:
- 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
- 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
- 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).
Who cannot join
- persons received antiparasitic drugs or antibiotic 2 weeks before sample collection Patients with mixed intestinal protozoa Patients with intestinal protozoa rather than Entamoeba histolytica and Blastocystis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University
Sohag
Youstina Kamel Boles, Demonstrator, +20 12 73435308, youstena.kamel@med.sohag.edu.eg
About this study
Calprotectin extracted from stool can be detected easily using ELISA. Numerous studies have shown that fecal calprotectin concentrations demonstrate a good correlation with intestinal inflammation This study aims to detect the relationship between fecal calprotectin and Blastocystis hominis and Entamoeba histolytica infections.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | 40 patients complaining of gastrointestinal manifestations and infected with Blastocystis or Entamoeba histolytica | |
| Control group 1 | 40 persons complaining of gastrointestinal manifestations without any protozoal infections | |
| Control group 2 | - 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Blastocystis and Entamoeba
Measured: 2 months
Secondary outcomes (1)
Number of persons have high fecal calprotectin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Calprotectin in Intestinal ProtozoaStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youstina Kamel Boles, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890455
- Sponsor's protocol ID
- Soh-Med--25-3-07MS
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections
- ClinicalTrials.gov ID
- NCT06890455
- Acronym / sponsor ID
- Soh-Med--25-3-07MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
Calprotectin extracted from stool can be detected easily using ELISA. Numerous studies have shown that fecal calprotectin concentrations demonstrate a good correlation with intestinal inflammation This study aims to detect the relationship between fecal calprotectin and Blastocystis hominis and Entamoeba histolytica infections.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –40 patients complaining of gastrointestinal manifestations and infected with Blastocystis or Entamoeba histolytica |
| Control group 1 | – | –40 persons complaining of gastrointestinal manifestations without any protozoal infections |
| Control group 2 | – | –- 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 120 fecal samples will be collected as the following: * 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica. * 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection. * 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).
Key inclusion criteria (4 listed)
- 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
- 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
- 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).
Key exclusion criteria (1 listed)
- persons received antiparasitic drugs or antibiotic 2 weeks before sample collection Patients with mixed intestinal protozoa Patients with intestinal protozoa rather than Entamoeba histolytica and Blastocystis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Blastocystis and Entamoeba
Time frame: 2 months
1 secondary outcome
Number of persons have high fecal calprotectin
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Undecided. Not decided yet
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Calprotectin in Intestinal Protozoa, run by Sohag University at 1 site in Egypt.
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 4 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: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youstina Kamel Boles, Demonstrator (+20 12 73435308, youstena.kamel@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 Blastocystis and Entamoeba (time frame: 2 months). 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 24 Mar 2025.