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Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis

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ClinicalTrials.gov Identifier: NCT05580393
Recruitment Status : Not yet recruiting
First Posted : October 14, 2022
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Shimaa Refaey Mohamed Abd-Elal, Sohag University

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Blastocystis Infections Diagnostic Test: RFLP analysis of SSU rRNA

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis in Sohag Governorate
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: RFLP analysis of SSU rRNA
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The number of cases with Blastocystis infection is recorded. [ Time Frame: 14 weeks following the startpoint of the study. ]
    By molecular examination of stool samples from 100 patients


Biospecimen Retention:   Samples With DNA
fecal specimens

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
samples will be collected from outpatients with any age & sex groups from different locations (cities and villages).
Criteria

Inclusion Criteria:

  • Patients from outpatient clinics, Sohag hospitals.

Exclusion Criteria:

  • Patients received antiparasitic drugs in the last two weeks
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05580393


Contacts
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Contact: Shimaa Refaey Mohamed Abd-Elal, assistant lecturer 01144981097 ext +20 Shimaa.refaee@med.sohag.edu.eg

Sponsors and Collaborators
Sohag University
More Information
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Responsible Party: Shimaa Refaey Mohamed Abd-Elal, Assistant Lecturer, Sohag University
ClinicalTrials.gov Identifier: NCT05580393    
Other Study ID Numbers: Soh-Med-22-10-16
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shimaa Refaey Mohamed Abd-Elal, Sohag University:
Blastocystis
colorectal cancer
irritable bowel syndrome
Additional relevant MeSH terms:
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Blastocystis Infections
Intestinal Diseases, Parasitic
Parasitic Diseases
Infections
Amebiasis
 Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases