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

Sohag University

Status: Not yet enrolling

Conditions: Blastocystis Infections

Treatments: Diagnostic Test: Fecal Calprotectin ELISA kit

Study type: Observational

Funder types: Other

Identifiers

NCT05724368

Soh-Med-23-01-24

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

Group 1

Description:

Patients with gastrointestinal symptoms and positive only for Blastocystis.

Treatment:

Diagnostic Test: Fecal Calprotectin ELISA kit

Group 2

Description:

Patients with gastrointestinal symptoms and Blastocystis free.

Treatment:

Diagnostic Test: Fecal Calprotectin ELISA kit

Group 3

Description:

Healthy volunteers with neither gastrointestinal symptoms nor parasitological infections.

Treatment:

Diagnostic Test: Fecal Calprotectin ELISA kit