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

NCT ID: NCT05724368

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2025-03-31

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Blastocystis Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Patients with gastrointestinal symptoms and positive only for Blastocystis.

Fecal Calprotectin ELISA kit

Intervention Type DIAGNOSTIC_TEST

* 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.

Fecal Calprotectin ELISA kit

Intervention Type DIAGNOSTIC_TEST

* 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.

Fecal Calprotectin ELISA kit

Intervention Type DIAGNOSTIC_TEST

* 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Refaey Mohamed Abd-Elal

Assistant lecturer of medical parasitology at the Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shimaa Refaey Mohamed AbdElal, Assistant Lecturer

Role: CONTACT

01144981097 ext. +20

Khoulood Zakaria Hashem Abd-Elhafez, Assistant Lecturer

Role: CONTACT

01127936972 ext. +20

Other Identifiers

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Soh-Med-23-01-24

Identifier Type: -

Identifier Source: org_study_id

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