Blastocystis InfectionsNCT05580393
Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis
An observational study of Blastocystis Infections, run by Sohag University.
Trial summary
Blastocystis is an anaerobic unicellular protozoal parasite infecting the gastrointestinal tract of humans and a wide range of animals. It is one of the most common enteric microorganisms with higher prevalence rates in developing than in developed countries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blastocystis Infections
- What is being tested?
- RFLP analysis of SSU rRNA
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 2023
- 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
- 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 received antiparasitic drugs in the last two weeks
Trial locations and contacts
No sites are listed yet.
Shimaa Refaey Mohamed Abd-Elal, assistant lecturer contact
About this study
Official title: Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis in Sohag Governorate
Blastocystis is an anaerobic unicellular protozoal parasite infecting the gastrointestinal tract of humans and a wide range of animals. It is one of the most common enteric microorganisms with higher prevalence rates in developing than in developed countries. Feco-oral is the main route of transmission where low socioeconomic conditions, poor hygienic practices, close contact with animals, and drinking contaminated water act as major risk factors. Infection with Blastocystis was demonstrated in both symptomatic and asymptomatic people. For a long period, Blastocystis was considered a commensal organism with no pathogenic role, but recently, many studies linked it to different gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. Association with irritable bowel syndrome and colorectal cancer was also reported.
This study aims to:
- Identify subtypes of human Blastocystis isolates in Sohag by using RFLP-PCR and provide additional information on the molecular epidemiology of this parasite in our locality.
- Conditions
- Blastocystis Infections
- Being tested
- RFLP analysis of SSU rRNA
- Keywords
- Blastocystis, colorectal cancer, irritable bowel syndrome
- Medical subject headings
- Blastocystis Infections, Colorectal Neoplasms, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFLP analysis of SSU rRNADiagnostic test
- Genomic DNA will be extracted from Blastocystis-positive fecal samples using a specific DNA Stool Mini Kit according to the manufacturer's instructions and will be stored at -20°C until use.
- PCR will be used to amplify a region of Blastocystis small subunit ribosomal RNA (SSU rRNA) gene.
- The amplified products for the SSU rRNA gene will be digested to determine the strain subtype of Blastocystis spp. using specific restriction enzymes.
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of cases with subtypes of human Blastocystis isolates in Sohag
by using RFLP-PCR
Measured: 14 weeks following the startpoint of the study.
Secondary outcomes (1)
The number of cases with Blastocystis infection is recorded.
By molecular examination of stool samples from 100 patients
Measured: 14 weeks following the startpoint of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionNov 2023 (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
- 100 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
- NCT05580393
- Sponsor's protocol ID
- Soh-Med-22-10-16
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- 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 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05580393
- Acronym / sponsor ID
- Soh-Med-22-10-16
- Conditions
- Blastocystis Infections
- Keywords
- Blastocystis, colorectal cancer, irritable bowel syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 14 Oct 2022 (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 is an anaerobic unicellular protozoal parasite infecting the gastrointestinal tract of humans and a wide range of animals. It is one of the most common enteric microorganisms with higher prevalence rates in developing than in developed countries. Feco-oral is the main route of transmission where low socioeconomic conditions, poor hygienic practices, close contact with animals, and drinking contaminated water act as major risk factors. Infection with Blastocystis was demonstrated in both symptomatic and asymptomatic people. For a long period, Blastocystis was considered a commensal organism with no pathogenic role, but recently, many studies linked it to different gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. Association with irritable bowel syndrome and colorectal cancer was also reported.
This study aims to:
- Identify subtypes of human Blastocystis isolates in Sohag by using RFLP-PCR and provide additional information on the molecular epidemiology of this parasite in our locality.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- 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 received antiparasitic drugs in the last 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 |
|---|---|---|
| RFLP analysis of SSU rRNA1. Genomic DNA will be extracted from Blastocystis-positive fecal samples using a specific DNA Stool Mini Kit according to the manufacturer's instructions and will be stored at -20°C until use. 2. PCR will be used to amplify a region of Blastocystis small subunit ribosomal RNA (SSU rRNA) gene. 3. The amplified products for the SSU rRNA gene will be digested to determine the strain subtype of Blastocystis spp. using specific restriction enzymes. | Diagnostic test | – |
Primary outcome
The number of cases with subtypes of human Blastocystis isolates in Sohag
Time frame: 14 weeks following the startpoint of the study.
by using RFLP-PCR
1 secondary outcome
The number of cases with Blastocystis infection is recorded.
Time frame: 14 weeks following the startpoint of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- 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 Abd-Elal, 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 14 Oct 2022. 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 Abd-Elal, 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?
The number of cases with subtypes of human Blastocystis isolates in Sohag (time frame: 14 weeks following the startpoint of the study.). 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 14 Oct 2022.