Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 1:37 AM
Study NCT ID:
NCT05580393
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-26', 'releaseDate': '2024-06-05'}], 'estimatedResultsFirstSubmitDate': '2024-06-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016776', 'term': 'Blastocystis Infections'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], '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'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'fecal specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of cases with subtypes of human Blastocystis isolates in Sohag', 'timeFrame': '14 weeks following the startpoint of the study.', 'description': 'by using RFLP-PCR'}], 'secondaryOutcomes': [{'measure': 'The number of cases with Blastocystis infection is recorded.', 'timeFrame': '14 weeks following the startpoint of the study.', 'description': 'By molecular examination of stool samples from 100 patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blastocystis', 'colorectal cancer', 'irritable bowel syndrome'], 'conditions': ['Blastocystis Infections']}, 'descriptionModule': {'briefSummary': 'Blastocystis is an anaerobic unicellular protozoal parasite infecting the gastrointestinal tract of humans and a wide range of animals. It is one of the most common enteric microorganisms with higher prevalence rates in developing than in developed countries. Feco-oral is the main route of transmission where low socioeconomic conditions, poor hygienic practices, close contact with animals, and drinking contaminated water act as major risk factors. Infection with Blastocystis was demonstrated in both symptomatic and asymptomatic people. For a long period, Blastocystis was considered a commensal organism with no pathogenic role, but recently, many studies linked it to different gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. Association with irritable bowel syndrome and colorectal cancer was also reported.\n\nThis study aims to:\n\n\\- Identify subtypes of human Blastocystis isolates in Sohag by using RFLP-PCR and provide additional information on the molecular epidemiology of this parasite in our locality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], '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 received antiparasitic drugs in the last two weeks'}, 'identificationModule': {'nctId': 'NCT05580393', 'briefTitle': 'Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis in Sohag Governorate', 'orgStudyIdInfo': {'id': 'Soh-Med-22-10-16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'RFLP analysis of SSU rRNA', 'type': 'DIAGNOSTIC_TEST', 'description': "1. Genomic DNA will be extracted from Blastocystis-positive fecal samples using a specific DNA Stool Mini Kit according to the manufacturer's instructions and will be stored at -20°C until use.\n2. PCR will be used to amplify a region of Blastocystis small subunit ribosomal RNA (SSU rRNA) gene.\n3. The amplified products for the SSU rRNA gene will be digested to determine the strain subtype of Blastocystis spp. using specific restriction enzymes."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shimaa Refaey Mohamed Abd-Elal, assistant lecturer', 'role': 'CONTACT', 'email': 'Shimaa.refaee@med.sohag.edu.eg', 'phone': '01144981097', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Shimaa Refaey Mohamed Abd-Elal', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-05', 'type': 'RELEASE'}, {'date': '2024-09-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shimaa Refaey Mohamed Abd-Elal, Assistant Lecturer, Sohag University'}}}}