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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blastocystis Infections
• Intervention / Treatment: Diagnostic test: RFLP analysis of SSU rRNA

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

samples will be collected from outpatients with any age & sex groups from different locations (cities and villages).

Description

Inclusion Criteria:

• Patients from outpatient clinics, Sohag hospitals.

Exclusion Criteria:

• Patients received antiparasitic drugs in the last two weeks

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of cases with subtypes of human Blastocystis isolates in Sohag	by using RFLP-PCR	14 weeks following the startpoint of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of cases with Blastocystis infection is recorded.	By molecular examination of stool samples from 100 patients	14 weeks following the startpoint of the study.

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: colorectal cancer; irritable bowel syndrome; Blastocystis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Parasitic Diseases; Protozoan Infections; Amebiasis; Blastocystis Infections
• Other Study ID Numbers: Soh-Med-22-10-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No