Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Intestinal Disease, Parasitic
• Intervention / Treatment: Diagnostic test: Tests for diagnosis of intestinal parasitic diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Poland
  • Kujawsko-Pomorskie
    • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-092
      • The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy people and inviduals with undiagnosed diseases or/and chronic symptoms such as: hay fever, skin and food allergies or eg. chronic fatigue.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study participants; Both healthy and ailing individuals, both sex, including adults and children.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Giardia antigen test	Stool test for Giardia lamblia antigen (ELISA kit)	1 day (single evalutaion of all samples through study completion)

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University
• Investigators: Principal Investigator: Paweł Sutkowy, PhD, Nicolaus Copernicus Univeristy

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (ACTUAL): April 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cryptosporidiosis; Toxoplasmosis; Echinococcosis; Ascariasis; Giardiasis; Trichinosis; Per os invasions; Taeniasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Disease Attributes; Gastrointestinal Diseases; Chronic Disease; Intestinal Diseases; Parasitic Diseases; Intestinal Diseases, Parasitic
• Other Study ID Numbers: KB 765/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No