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Trial Title:
Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis
NCT ID:
NCT05580393
Condition:
Blastocystis Infections
Conditions: Official terms:
Blastocystis Infections
Conditions: Keywords:
Blastocystis
colorectal cancer
irritable bowel syndrome
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
RFLP analysis of SSU rRNA
Description:
1. 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.
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. 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.
Criteria for eligibility:
Study pop:
samples will be collected from outpatients with any age & sex groups from different
locations (cities and villages).
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients from outpatient clinics, Sohag hospitals.
Exclusion Criteria:
- Patients received antiparasitic drugs in the last two weeks
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
November 2022
Completion date:
November 2023
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05580393
