Blastocystis Hominis InfectionsNCT05814861
Isolation and Characterization of Blastocystis Hominis as Apotential Human Pathogen
An observational study of Blastocystis Hominis Infections, run by Assiut University.
Trial summary
Detection of the presence of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals in comparison with those in control group. Assessment of different culture techniques for detection, and isolation of Blastocystis hominis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blastocystis Hominis Infections
- What is being tested?
- culture and PCR
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The persons selected for the study are those who are: 1. Suffering from any GIT manifestations, attending outpatient clinics of Internal Medicine and Tropical Medicine Departments at Assiut University Hospitals (case group) * GIT manifestations such as diarrhea; (frequency ≥3 loose stool /day), either acute diarrhea (duration less than 2 weeks), or chronic diarrhea (duration more than 4 weeks), or other GIT complaints as abdominal pain, flatulence, nausea, vomiting, or weight loss. 2. clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)
Who may be able to join
- The persons selected for the study are those who are:
- Suffering from any GIT manifestations, attending outpatient clinics of Internal Medicine and Tropical Medicine Departments at Assiut University Hospitals (case group)
- clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)
Who cannot join
- We will exclude any patient who received antibiotic or anti-parasitic drugs the past 4 weeks prior to sample collection.
Trial locations and contacts
No sites are listed yet.
About this study
- Detection of the presence of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals in comparison with those in control group.
- Assessment of different culture techniques for detection, and isolation of Blastocystis hominis.
- Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).
Read the detailed description
Blastocystis is a genus of single-celled parasites belonging to a group of organisms that are known as the Stramenopiles . Blastocystis consists of several species, living in the gastrointestinal tracts of humans and farm animals. Many different species can infect humans and would be identified as Blastocystis hominis depending on the sequencing of the gene encoding the 18S rRNA . Among the subtypes recognized, ST1-8 could colonize humans as well as animals.
Infection with B. hominis has a worldwide distribution with infection rate reaches up to 60% in developing countries. Initially B.hominis was accepted as a harmless commensal in the intestinal tract, but recently it was implicated as a pathogen. As it able to produce a cysteine protease which breaks up the mucosal IgA antibody. B.hominis infection has been associated with several gastrointestinal symptoms, Even though most cases are asymptomatic, it is also play a significant role in some chronic gastrointestinal illnesses as irritable bowel syndrome (IBS).
Blastocystis spp. are polymorphic parasites with multiple morphological forms including vacuolar, multivacuolar, granular, ameboid, and cystic forms. At least two out of three infections may be missed during microscopic detection of B.hominis due to their polymorphic nature, and the possibility of confusion with yeast, Cyclospora spp. or fat globules. . Different studies suggested that it multiply rapidly in culture medium and considered it a sensitive method for diagnosis of B.hominis . Recently Molecular diagnosis by polymerase chain reaction (PCR) is considered the most sensitive method for the detection of B.hominis.
- Conditions
- Blastocystis Hominis Infections
- Being tested
- culture and PCR
- Medical subject headings
- Blastocystis Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture and PCRDiagnostic test
Stool samples will be cultured inTwo media :
A-Locke egg serum medium (LE) B- Jones' medium Then Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).
| Study group | Role | What they receive |
|---|---|---|
| patients presented with GIT symptoms | Fresh Stool samples will be collected in clean sterile cups from patients suffering from gastrointestinal symptoms attending Assiut University Hospitals and examined for detection of Blastocystis hominis Receives: Diagnostic Test: culture and PCR | |
| clinically free persons undergo routine stool analysis for any reasons other than GIT complaint | Fresh Stool samples will be collected in clean sterile cups from clinically free persons under go routine stool examination for any cause other than GIT troubles and examined for detection of Blastocystis hominis Receives: Diagnostic Test: culture and PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Morphological identification of Blastocystis hominis in stool.
Microscopic Detection of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals .
Measured: 1year
Secondary outcomes (1)
Molecular identification of Blastocystis hominis
Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blastocystis Hominis InfectionsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Alzahraa Montaser Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814861
- Sponsor's protocol ID
- Blastocystis hominis isolation
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
A. F. Bafghi, R. Hosseini, H. R. Mollaei, and K. Barzegar, "Geno-typing and Comparison of Conventional and Molecular Diagnostic Techniques for Detection of Blastocystis on health centers in Kerman , Iran," vol. 8, no. 01, pp. 10-16, 2021..
S M. Journal, "SOHAG MEDICAL JOURNAL Vol. 21 No.3," vol. 21, no. 3, 2017.
M. Q. Khairuzzaman, "No Title血清及尿液特定蛋白检测在糖尿病肾病早期诊断中的意义," vol. 4, no. 1, pp. 64-75, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation and Characterization of Blastocystis Hominis as Apotential Human Pathogen
- ClinicalTrials.gov ID
- NCT05814861
- Acronym / sponsor ID
- Blastocystis hominis isolation
- Conditions
- Blastocystis Hominis Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 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.
- Detection of the presence of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals in comparison with those in control group.
- Assessment of different culture techniques for detection, and isolation of Blastocystis hominis.
- Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).
Detailed description
Blastocystis is a genus of single-celled parasites belonging to a group of organisms that are known as the Stramenopiles . Blastocystis consists of several species, living in the gastrointestinal tracts of humans and farm animals. Many different species can infect humans and would be identified as Blastocystis hominis depending on the sequencing of the gene encoding the 18S rRNA . Among the subtypes recognized, ST1-8 could colonize humans as well as animals.
Infection with B. hominis has a worldwide distribution with infection rate reaches up to 60% in developing countries. Initially B.hominis was accepted as a harmless commensal in the intestinal tract, but recently it was implicated as a pathogen. As it able to produce a cysteine protease which breaks up the mucosal IgA antibody. B.hominis infection has been associated with several gastrointestinal symptoms, Even though most cases are asymptomatic, it is also play a significant role in some chronic gastrointestinal illnesses as irritable bowel syndrome (IBS).
Blastocystis spp. are polymorphic parasites with multiple morphological forms including vacuolar, multivacuolar, granular, ameboid, and cystic forms. At least two out of three infections may be missed during microscopic detection of B.hominis due to their polymorphic nature, and the possibility of confusion with yeast, Cyclospora spp. or fat globules. . Different studies suggested that it multiply rapidly in culture medium and considered it a sensitive method for diagnosis of B.hominis . Recently Molecular diagnosis by polymerase chain reaction (PCR) is considered the most sensitive method for the detection of B.hominis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients presented with GIT symptoms | – | Diagnostic Test: culture and PCRFresh Stool samples will be collected in clean sterile cups from patients suffering from gastrointestinal symptoms attending Assiut University Hospitals and examined for detection of Blastocystis hominis |
| clinically free persons undergo routine stool analysis for any reasons other than GIT complaint | – | Diagnostic Test: culture and PCRFresh Stool samples will be collected in clean sterile cups from clinically free persons under go routine stool examination for any cause other than GIT troubles and examined for detection of Blastocystis hominis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The persons selected for the study are those who are: 1. Suffering from any GIT manifestations, attending outpatient clinics of Internal Medicine and Tropical Medicine Departments at Assiut University Hospitals (case group) * GIT manifestations such as diarrhea; (frequency ≥3 loose stool /day), either acute diarrhea (duration less than 2 weeks), or chronic diarrhea (duration more than 4 weeks), or other GIT complaints as abdominal pain, flatulence, nausea, vomiting, or weight loss. 2. clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)
Key inclusion criteria (3 listed)
- The persons selected for the study are those who are:
Key exclusion criteria (1 listed)
- We will exclude any patient who received antibiotic or anti-parasitic drugs the past 4 weeks prior to sample collection.
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 |
|---|---|---|
| culture and PCRStool samples will be cultured inTwo media : A-Locke egg serum medium (LE) B- Jones' medium Then Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR). | Diagnostic test | clinically free persons undergo routine stool analysis for any reasons other than GIT complaint, patients presented with GIT symptoms |
Primary outcome
-Morphological identification of Blastocystis hominis in stool.
Time frame: 1year
Microscopic Detection of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals .
1 secondary outcome
Molecular identification of Blastocystis hominis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- BackgroundA. F. Bafghi, R. Hosseini, H. R. Mollaei, and K. Barzegar, "Geno-typing and Comparison of Conventional and Molecular Diagnostic Techniques for Detection of Blastocystis on health centers in Kerman , Iran," vol. 8, no. 01, pp. 10-16, 2021..
- BackgroundS M. Journal, "SOHAG MEDICAL JOURNAL Vol. 21 No.3," vol. 21, no. 3, 2017.
- BackgroundM. Q. Khairuzzaman, "No Title血清及尿液特定蛋白检测在糖尿病肾病早期诊断中的意义," vol. 4, no. 1, pp. 64-75, 2016.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blastocystis Hominis Infections, run by Assiut 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 3 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 18 Apr 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 Fatma Alzahraa montaser Ali, demonstrator (01060093655, docfatma490@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Morphological identification of Blastocystis hominis in stool. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814861, which also lists 3 linked publications.
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 18 Apr 2023.