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

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05724368

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Blastocystis Infections	Diagnostic Test: Fecal Calprotectin ELISA kit

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	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.

Arm

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

Group 3

Healthy volunteers with neither gastrointestinal symptoms nor parasitological infections.

Diagnostic Test: Fecal Calprotectin ELISA kit

Outcome Measures

Primary Outcome Measures

level of fecal calprotectin [1 month]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shimaa Refaey Mohamed Abd-Elal, Assistant lecturer of medical parasitology at the Faculty of Medicine, Sohag University

ClinicalTrials.gov Identifier:

NCT05724368

Other Study ID Numbers:

Soh-Med-23-01-24

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shimaa Refaey Mohamed Abd-Elal, Assistant lecturer of medical parasitology at the Faculty of Medicine, Sohag University

Blastocystis

Calprotectin

Additional relevant MeSH terms:

Infections

Communicable Diseases

Blastocystis Infections

Study Results

No Results Posted as of Feb 13, 2023