Intestinal Disease, ParasiticNCT03490435
Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland
An observational study of Intestinal Disease, Parasitic and Chronic Disease, run by Nicolaus Copernicus University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Disease, Parasitic, Chronic Disease
- What is being tested?
- Tests for diagnosis of intestinal parasitic diseases
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 17 Feb 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- healthy and ailing individuals
- men and females
- adults and children
Who cannot join
- the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-092
About this study
Official title: 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.
Read the 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.
- Conditions
- Intestinal Disease, Parasitic, Chronic Disease
- Being tested
- Tests for diagnosis of intestinal parasitic diseases
- Keywords
- Per os invasions, Giardiasis, Toxoplasmosis, Taeniasis, Cryptosporidiosis, Trichinosis, Ascariasis, Echinococcosis
- Medical subject headings
- Intestinal Diseases, Parasitic, Chronic Disease, Giardiasis, Toxoplasmosis, Taeniasis, Cryptosporidiosis, Trichinellosis, Ascariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests for diagnosis of intestinal parasitic diseasesDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Both healthy and ailing individuals, both sex, including adults and children. Receives: Diagnostic Test: Tests for diagnosis of intestinal parasitic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (single evaluation of current samples)
Giardia antigen test
Stool test for Giardia lamblia antigen (ELISA kit)
Measured: 1 day (single evalutaion of all samples through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start17 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Disease, ParasiticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Sutkowy, Nicolaus Copernicus University
- Investigators
- Paweł Sutkowy, PhD, Principal investigator, Nicolaus Copernicus Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490435
- Sponsor's protocol ID
- KB 765/2016
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics of Intestinal Parasitosis in Inhabitants of Kuyavian-Pomeranian Province in Poland
- ClinicalTrials.gov ID
- NCT03490435
- Acronym / sponsor ID
- KB 765/2016
- Conditions
- Intestinal Disease, Parasitic, Chronic Disease
- Keywords
- Per os invasions, Giardiasis, Toxoplasmosis, Taeniasis, Cryptosporidiosis, Trichinosis, Ascariasis, Echinococcosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 17 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | – | Diagnostic Test: Tests for diagnosis of intestinal parasitic diseasesBoth healthy and ailing individuals, both sex, including adults and children. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- healthy and ailing individuals
- men and females
- adults and children
Key exclusion criteria (1 listed)
- the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tests for diagnosis of intestinal parasitic diseasesFeces testing: 1. 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™ 2. 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) | Diagnostic test | Study participants |
Primary outcome
Intestinal parasites
Time frame: 1 day (single evaluation of current samples)
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.
Giardia antigen test
Time frame: 1 day (single evalutaion of all samples through study completion)
Stool test for Giardia lamblia antigen (ELISA kit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Sutkowy, PhD principal investigator
Nicolaus Copernicus Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Disease, Parasitic and Chronic Disease, run by Nicolaus Copernicus University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal parasites (time frame: 1 day (single evaluation of current samples)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.