Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 11:55 PM
Study NCT ID:
NCT04708405
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by disease related symptoms \\[weight loss where weight will be measured and reported in kilograms\\]'}, {'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by frequency of disease related symptoms \\[number of attacks disease related symptoms per day (diarrhea, tenesmus, bleeding per rectum, abdominal pain, indigestion)\\]'}, {'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples \\[C reactive protein (IU/ml)\\]'}, {'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples \\[Hemoglobin (g/dl)\\]'}, {'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in blood samples \\[Complete blood picture including white blood count per cmm, platelets count per cmm\\]'}, {'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples \\[ESR (mm/hr)\\]'}, {'measure': 'Change in the inflammatory bowel disease condition', 'timeFrame': '3 months', 'description': 'Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples \\[Fasting blood glucose (mg/dl)\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Diseases', 'Helicobacter Pylori', 'Egypt'], 'conditions': ['Inflammatory Bowel Diseases', 'Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. pylori infection and IBD and its impact on disease course. The investigators sought to conduct a prospective observational study and enroll a total of 182 IBD patients who were screened for H. pylori infection. All the participants will be clinically evaluated at the initial visit and bimonthly for 3 months. Several factors will be explored such are diet, physical activity, life style and considering specific environmental exposures that impact the development of disease or its relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagnosed with inflammatory bowel disease condition', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with inflammatory bowel disease condition\n\nExclusion Criteria:\n\n* Having irritable bowel disease\n* Being younger than 18 years'}, 'identificationModule': {'nctId': 'NCT04708405', 'briefTitle': 'The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation', 'orgStudyIdInfo': {'id': '622-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inflammatory bowel disease patients', 'description': 'Inflammatory bowel disease patients screened for Helicobacter Pylori Infection', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Follow up and observe under standard of care given', 'armGroupLabels': ['Inflammatory bowel disease patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21561', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'High Institute of Public Health', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'High Institute of Public Health, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ekram Abdel Wahab', 'investigatorAffiliation': 'Alexandria University'}}}}