Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 8:16 PM
Study NCT ID:
NCT05002166
Status:
RECRUITING
Last Update Posted:
2021-08-12
First Post:
2021-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical characteristics and risk factors for IBD', 'timeFrame': '6 months', 'description': 'To study the natural history, patterns, and clinical characteristics (as history of real bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting)and risk factors of inflammatory bowel diseases (IBD) at Assiut University Children Hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': 'Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital', 'detailedDescription': 'All patients admitted with inflammatory bowel disease will be subjected to:\n\n1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.\n2. Examination: including general examination, chest, cardiac, abdominal and neurological examination\n3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted with inflammatory bowel disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Children aged less than 18 years with a confirmed diagnosis of IBD.\n\nExclusion Criteria:\n\n* Children with colitis other than IBD or children with systemic diseases affecting GIT.'}, 'identificationModule': {'nctId': 'NCT05002166', 'briefTitle': 'Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital', 'orgStudyIdInfo': {'id': 'Infilamatory bowel disease'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children aged less than 18 years with a confirmed diagnosis of IBD.', 'description': 'All patients admitted with inflammatory bowel disease will be subjected to:\n\n1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.\n2. Examination: including general examination, chest, cardiac, abdominal and neurological examination\n3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.', 'interventionNames': ['Other: labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.']}], 'interventions': [{'name': 'labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.', 'type': 'OTHER', 'description': 'labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.', 'armGroupLabels': ['Children aged less than 18 years with a confirmed diagnosis of IBD.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23123', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Christine Zaghloul, Resident', 'role': 'CONTACT', 'email': 'christinezaghloul@gmail.com', 'phone': '01289132810'}, {'name': 'Shereen Mansour, Lecturer', 'role': 'CONTACT', 'email': 'Shyreen.ahmed@med.au.edu.eg', 'phone': '01003162310'}], 'facility': 'Christine zaghloul noos', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Christine Zaghloul, Resident', 'role': 'CONTACT', 'email': 'christinezaghloul@gmail.com', 'phone': '01289132810'}, {'name': 'Maher Mokhtar, Professor', 'role': 'CONTACT', 'email': 'maher.mokhtar@gmail.com', 'phone': '01062052802'}], 'overallOfficials': [{'name': 'Shereen Mansour, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Christine Zaghloul Noos', 'investigatorAffiliation': 'Assiut University'}}}}