Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland

Chronic Disease Clinical Trial

Official title:

Diagnostics of Intestinal Parasitosis in Inhabitants of Kuyavian-Pomeranian Province in Poland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490435
• Other study ID #: KB 765/2016
• Status: Completed
• Start date: February 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Nicolaus Copernicus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of the proposed study is to assess the prevalence of intestinal parasitic diseases in adults and children. These invasions are included to "dirty hand diseases" (per os invasions), therefore it applies mainly preschool children.

Description:

It is estimated that 75% of the world's population is infected with parasites and although parasitic diseases are mostly observed in the poor tropical and subtropical countries, there are also many diseases caused by parasites in Poland. In Poland, particular attention is paid to the following parasitic diseases closely related to the digestive system: giardiasis, taeniasis (including cysticercosis), ascariasis, cryptosporidiosis, toxoplasmosis, trichinosis, echinococcosis.

Symptoms of such invasions may include: allergic rhinitis of unknown origin, chronic fatigue or food intolerance. Moreover, many of them are asymptotic, therefore the study group will consist of both healthy people and individuals with undiagnosed diseases or/and chronic symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• healthy and ailing individuals

• men and females

• adults and children

Exclusion Criteria:

• the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators

Related Conditions & MeSH terms

• Chronic Disease
• Intestinal Disease, Parasitic
• Intestinal Diseases
• Intestinal Diseases, Parasitic
• Parasitic Diseases

Intervention

Diagnostic Test:
• Tests for diagnosis of intestinal parasitic diseases
Feces testing: fresh fecal samples will be used to preparing direct (saline and iodine wet) mounts using supplementary techniques (flotation, sedimentation), as well as temporary mounts (hematoxylin and trichrome staining). Other technique of fresh fecal samples examination will be ParaSys™ A non-preserved stool samples will be stored below -20°C. Defrosted fecal specimen will be subjected to enzyme-linked immunosorbent assays (ELISA) - Giardia antigen test (coproantigens)

Locations

Country	Name	City	State
Poland	The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University	Bydgoszcz	Kujawsko-Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal parasites	The fecal samples will be assessed qualitavely in terms of life forms of parasites present in human intestine, i.e.: eggs and larvas of flukes, tapeworms and nematodes, as well as protozoa trophozoites and cysts.	1 day (single evaluation of current samples)
Primary	Giardia antigen test	Stool test for Giardia lamblia antigen (ELISA kit)	1 day (single evalutaion of all samples through study completion)