Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 7:35 AM
Study NCT ID:
NCT05724368
Status:
UNKNOWN
Last Update Posted:
2023-02-13
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016776', 'term': 'Blastocystis Infections'}], 'ancestors': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000562', 'term': 'Amebiasis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'fecal specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of fecal calprotectin', 'timeFrame': '1 month', 'description': 'Evaluation of fecal calprotectin inflammation levels of Blastocystis hominis in patients with gastrointestinal troubles as compared to patients with gastrointestinal troubles but without Blastocystis hominis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blastocystis', 'Calprotectin'], 'conditions': ['Blastocystis Infections']}, 'descriptionModule': {'briefSummary': '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%).\n\nIn 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 .', 'detailedDescription': '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%).\n\nIn 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.\n\nCalprotectin (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'samples will be collected from outpatients with any age \\& sex groups from different locations (cities and villages).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from outpatient clinics, Sohag hospitals.\n\nExclusion Criteria:\n\n* Patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.'}, 'identificationModule': {'nctId': 'NCT05724368', 'briefTitle': 'Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection', 'orgStudyIdInfo': {'id': 'Soh-Med-23-01-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with gastrointestinal symptoms and positive only for Blastocystis.', 'interventionNames': ['Diagnostic Test: Fecal Calprotectin ELISA kit']}, {'label': 'Group 2', 'description': 'Patients with gastrointestinal symptoms and Blastocystis free.', 'interventionNames': ['Diagnostic Test: Fecal Calprotectin ELISA kit']}, {'label': 'Group 3', 'description': 'Healthy volunteers with neither gastrointestinal symptoms nor parasitological infections.', 'interventionNames': ['Diagnostic Test: Fecal Calprotectin ELISA kit']}], 'interventions': [{'name': 'Fecal Calprotectin ELISA kit', 'type': 'DIAGNOSTIC_TEST', 'description': "* Routine stool examination will be done in addition to certain concentration, staining and culture techniques.\n* Fecal calprotectin will be evaluated using ELISA kits according to the manufacturer's instructions.", 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shimaa Refaey Mohamed AbdElal, Assistant Lecturer', 'role': 'CONTACT', 'email': 'Shimaa.refaee@med.sohag.edu.eg', 'phone': '01144981097', 'phoneExt': '+20'}, {'name': 'Khoulood Zakaria Hashem Abd-Elhafez, Assistant Lecturer', 'role': 'CONTACT', 'email': 'Khoulood.zakaria@med.sohag.edu.eg', 'phone': '01127936972', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of medical parasitology at the Faculty of Medicine', 'investigatorFullName': 'Shimaa Refaey Mohamed Abd-Elal', 'investigatorAffiliation': 'Sohag University'}}}}