Isolation and Characterization of Blastocystis Hominis as Apotential Human Pathogen

• 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Blastocystis Hominis Infections
• Intervention / Treatment: Diagnostic test: culture and 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 Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Fatma Alzahraa montaser Ali, demonstrator; Phone Number: 01060093655; Email: docfatma490@gmail.com
• Study Contact Backup: Name: magda mohamed atiya Elnazer, Prof.; Phone Number: 01143533100; Email: Magda.elnazer@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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)

Description

Inclusion Criteria:

• 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)
  2. clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)

Exclusion Criteria:

• We will exclude any patient who received antibiotic or anti-parasitic drugs the past 4 weeks prior to sample collection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: culture and PCR; 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).
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	Diagnostic test: culture and PCR; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
-Morphological identification of Blastocystis hominis in stool.	Microscopic Detection of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals .	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular identification of Blastocystis hominis	Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• 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: Blastocystis hominis isolation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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