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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05724368
Enrollment
150
Registered
2023-02-13
Start date
2023-03-31
Completion date
2025-03-31
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blastocystis Infections

Keywords

Blastocystis, Calprotectin

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 .

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.

Interventions

DIAGNOSTIC_TESTFecal 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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
level of fecal calprotectin1 monthEvaluation of fecal calprotectin inflammation levels of Blastocystis hominis in patients with gastrointestinal troubles as compared to patients with gastrointestinal troubles but without Blastocystis hominis

Contacts

Primary ContactShimaa Refaey Mohamed AbdElal, Assistant Lecturer
Shimaa.refaee@med.sohag.edu.eg01144981097
Backup ContactKhoulood Zakaria Hashem Abd-Elhafez, Assistant Lecturer
Khoulood.zakaria@med.sohag.edu.eg01127936972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026