Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection

Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).

In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food .

Study Overview

• Status: Not yet recruiting
• Conditions: Blastocystis Infections
• Intervention / Treatment: Diagnostic test: Fecal Calprotectin ELISA kit

Detailed Description

Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).

In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food. The pathogenicity of Blastocystis is controversial because most patients carrying this parasite are asymptomatic. Several studies have considered Blastocystis sp. as a commensal micro-organism, while other results have showed the pathogenicity of the parasite.

Calprotectin (CP), a calcium-binding protein, comprises 60% of cytosolic protein found in neutrophils. Fecal calprotectin (F-CP) concentration is an indicator of neutrophil migration into the intestinal lumen and is associated with intestinal inflammation.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Shimaa Refaey Mohamed AbdElal, Assistant Lecturer; Phone Number: +20 01144981097; Email: Shimaa.refaee@med.sohag.edu.eg
• Study Contact Backup: Name: Khoulood Zakaria Hashem Abd-Elhafez, Assistant Lecturer; Phone Number: +20 01127936972; Email: Khoulood.zakaria@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• 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 taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients with gastrointestinal symptoms and positive only for Blastocystis.	Diagnostic test: Fecal Calprotectin ELISA kit; Routine stool examination will be done in addition to certain concentration, staining and culture techniques.; Fecal calprotectin will be evaluated using ELISA kits according to the manufacturer's instructions.
Group 2; Patients with gastrointestinal symptoms and Blastocystis free.	Diagnostic test: Fecal Calprotectin ELISA kit; Routine stool examination will be done in addition to certain concentration, staining and culture techniques.; Fecal calprotectin will be evaluated using ELISA kits according to the manufacturer's instructions.
Group 3; Healthy volunteers with neither gastrointestinal symptoms nor parasitological infections.	Diagnostic test: Fecal Calprotectin ELISA kit; Routine stool examination will be done in addition to certain concentration, staining and culture techniques.; Fecal calprotectin will be evaluated using ELISA kits according to the manufacturer's instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of fecal calprotectin	Evaluation of fecal calprotectin inflammation levels of Blastocystis hominis in patients with gastrointestinal troubles as compared to patients with gastrointestinal troubles but without Blastocystis hominis	1 month

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): March 1, 2025

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Calprotectin; Blastocystis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Parasitic Diseases; Protozoan Infections; Amebiasis; Infections; Communicable Diseases; Blastocystis Infections
• Other Study ID Numbers: Soh-Med-23-01-24

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