Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT03490435
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D005873', 'term': 'Giardiasis'}, {'id': 'D014123', 'term': 'Toxoplasmosis'}, {'id': 'D013622', 'term': 'Taeniasis'}, {'id': 'D003457', 'term': 'Cryptosporidiosis'}, {'id': 'D014235', 'term': 'Trichinellosis'}, {'id': 'D001196', 'term': 'Ascariasis'}, {'id': 'D004443', 'term': 'Echinococcosis'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D002590', 'term': 'Cestode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D011529', 'term': 'Protozoan Infections, Animal'}, {'id': 'D010273', 'term': 'Parasitic Diseases, Animal'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D017189', 'term': 'Enoplida Infections'}, {'id': 'D017188', 'term': 'Adenophorea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D017191', 'term': 'Ascaridida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Feces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal parasites', 'timeFrame': '1 day (single evaluation of current samples)', 'description': '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.'}, {'measure': 'Giardia antigen test', 'timeFrame': '1 day (single evalutaion of all samples through study completion)', 'description': 'Stool test for Giardia lamblia antigen (ELISA kit)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Per os invasions', 'Giardiasis', 'Toxoplasmosis', 'Taeniasis', 'Cryptosporidiosis', 'Trichinosis', 'Ascariasis', 'Echinococcosis'], 'conditions': ['Intestinal Disease, Parasitic', 'Chronic Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nSymptoms 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy people and inviduals with undiagnosed diseases or/and chronic symptoms such as: hay fever, skin and food allergies or eg. chronic fatigue.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy and ailing individuals\n* men and females\n* adults and children\n\nExclusion Criteria:\n\n* the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators'}, 'identificationModule': {'nctId': 'NCT03490435', 'briefTitle': 'Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland', 'organization': {'class': 'OTHER', 'fullName': 'Nicolaus Copernicus University'}, 'officialTitle': 'Diagnostics of Intestinal Parasitosis in Inhabitants of Kuyavian-Pomeranian Province in Poland', 'orgStudyIdInfo': {'id': 'KB 765/2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study participants', 'description': 'Both healthy and ailing individuals, both sex, including adults and children.', 'interventionNames': ['Diagnostic Test: Tests for diagnosis of intestinal parasitic diseases']}], 'interventions': [{'name': 'Tests for diagnosis of intestinal parasitic diseases', 'type': 'DIAGNOSTIC_TEST', 'description': 'Feces testing:\n\n1. 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™\n2. 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)', 'armGroupLabels': ['Study participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-092', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'overallOfficials': [{'name': 'Paweł Sutkowy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nicolaus Copernicus Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicolaus Copernicus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Paweł Sutkowy', 'investigatorAffiliation': 'Nicolaus Copernicus University'}}}}