Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03269305
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Audit on Management of Chronic Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proper management of chronic diarrhea', 'timeFrame': 'september 2017-september 2018', 'description': 'start accurate treatment of chronic diarrhea by reaching a definitive cause of each case .\n\ndecrease the incidence of undiagnosed cases of chronic diarrhea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Diarrhea']}, 'descriptionModule': {'briefSummary': "The study is to assess whether the staff in gastroenterology unit are sticking to the agreed up on unit's protocol in management of chronic diarrhea over the period of one year(september 2017-september 2018)", 'detailedDescription': "chronic diarrhea is defined as having loose or watery stools more than three times aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some cases chronic diarrhea is the result of intestinal infection that persists longer than expected. In other cases chronic diarrhea is apart of a systemic illness.\n\nEtiology:\n\n1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a cause.\n2. infectious causes:enteric infection is an important cause.Associated conditions may be T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging or acquiring another infection.Viral infection like Rota virus,parasites as E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.\n3. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno compromised patients.\n4. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory bowel disease,all of which may cause chronic diarrhea that is often associated with abdominal pain with or without elevated levels of inflammatory markers.\n5. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually fatty in nature and bulky in amount.\n\nGood management of chronic diarrhea must include investigations and treatment.A protocol must be followed accurately therefore.\n\nMethodology:\n\nmeasurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon unit's protocol in management of chronic diarrhea over the period of one year (September 2017-September 2018)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'an audit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age group from 2 months to 18 years\n* cases with diarrhea lasts 2 weeks or more\n* Genetically free\n\nExclusion Criteria:\n\n* age group from 0-2 months\n* age group above 18 years\n* cases with diarrhea less than 2 weeks\n* Gentic disease'}, 'identificationModule': {'nctId': 'NCT03269305', 'acronym': 'AAOMOCD', 'briefTitle': 'An Audit on Management of Chronic Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'An Audit on Management of Chronic Diarrhea', 'orgStudyIdInfo': {'id': 'AssiutU71515'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Gehad', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Faisal Alkhateeb, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gehad Adel Mohammed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assiut University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Gehad Adel Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}