Viewing Study NCT01593592


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Study NCT ID: NCT01593592
Status: COMPLETED
Last Update Posted: 2015-08-17
First Post: 2012-05-05
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emara_20007@yahoo.com', 'phone': '+2 0100 272 4482', 'title': 'Dr Mohamed Emara', 'organization': 'Tropical Medicine Departement, Faculty of Medicine, Zagazig University, Egypt'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'no limitations'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Patients were followed up for 8 weeks to report any adverse events and side effects', 'eventGroups': [{'id': 'EG000', 'title': 'Lactobacillus Reuteri Group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri\n\nLactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.', 'otherNumAtRisk': 35, 'otherNumAffected': 10, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The control group that will receive the standard triple therapy and placebo\n\nPlacebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.', 'otherNumAtRisk': 35, 'otherNumAffected': 25, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Galactorrhea', 'notes': 'one virgin female patient developed galactorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Eradication of H Pylori Infection 4 Weeks After Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group that will receive the standard triple therapy and placebo\n\nPlacebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Lactobacillus Reuteri Group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri\n\nLactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks therapy', 'description': 'H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'It is assessment of all the 70 participants about H pylori eradication status'}, {'type': 'SECONDARY', 'title': 'Severe Adverse Effects to the Used Medications and Dietary Supplements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group that will receive the standard triple therapy and placebo\n\nPlacebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Lactobacillus Reuteri Group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri\n\nLactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'groupDescription': 'A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The control group that will receive the standard triple therapy and placebo\n\nPlacebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Lactobacillus Reuteri Group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri\n\nLactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'The control group that will receive the standard triple therapy and placebo\n\nPlacebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.'}, {'id': 'FG001', 'title': 'Lactobacillus Reuteri Group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri\n\nLactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All adult dyspeptic patients presented to outpatient gastroenterology clinics of the Tropical Medicine and Internal Medicine Departments, Faculty of Medicine, Zagazig University Hospitals, Egypt from June 2012 to February 2013 were offered to share in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactobacillus Reuteri Group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The control group that will receive the standard triple therapy and placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.20', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '36.80', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '60'}, {'value': '35.00', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ِAge', 'classes': [{'categories': [{'measurements': [{'value': '33.20', 'spread': '13.974', 'groupId': 'BG000'}, {'value': '36.80', 'spread': '11.085', 'groupId': 'BG001'}, {'value': '35.00', 'spread': '12.650', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'It is a measure of age from 18 to 60 years old for participants', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All were dyspeptic patients'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-19', 'studyFirstSubmitDate': '2012-05-05', 'resultsFirstSubmitDate': '2015-03-07', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-19', 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication of H Pylori Infection 4 Weeks After Completion of Therapy', 'timeFrame': '4 weeks therapy', 'description': 'H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.'}], 'secondaryOutcomes': [{'measure': 'Severe Adverse Effects to the Used Medications and Dietary Supplements.', 'timeFrame': '4 weeks'}, {'measure': 'The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.', 'timeFrame': '8 weeks', 'description': 'Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Lactobacillus reuteri', 'dyspeptic patients', 'eradication'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hosp.zu.edu.eg/', 'label': 'Study location Hospital'}]}, 'descriptionModule': {'briefSummary': 'Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.', 'detailedDescription': 'Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion of patients with these criteria\n\n1. Age: 18-60 years\n2. Any sex\n3. Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool\n4. Good mentality to understand aim, benefits and steps of the study\n5. Assumed availability during the study period\n6. Written informed consent\n\nExclusion Criteria:\n\n* Exclusion of\n\n 1. Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc.\n 2. Patients with malignancy.\n 3. Patients with gall bladder disorders.\n 4. Patients with peptic ulcer.\n 5. Patients with prior upper GIT surgery.\n 6. Patients with probiotics therapy in the last one month.\n 7. Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.\n 8. Patients with known allergy to the used medications\n\n \\-'}, 'identificationModule': {'nctId': 'NCT01593592', 'briefTitle': 'Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB#:395/29-4-2012'}, 'secondaryIdInfos': [{'id': 'IRB#:395/29-4-2012', 'type': 'OTHER', 'domain': 'Zagazig University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus reuteri group', 'description': 'The active group that will receive the standard triple therapy and Lactobacillus reuteri', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri', 'Drug: Omeprazole', 'Drug: Amoxicillin', 'Drug: Clarithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The control group that will receive the standard triple therapy and placebo', 'interventionNames': ['Dietary Supplement: Placebo', 'Drug: Omeprazole', 'Drug: Amoxicillin', 'Drug: Clarithromycin']}], 'interventions': [{'name': 'Lactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.', 'armGroupLabels': ['Lactobacillus reuteri group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.', 'armGroupLabels': ['Control group']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'All patients will receive omeprazole 20 mg b.i.d for 2 week', 'armGroupLabels': ['Control group', 'Lactobacillus reuteri group']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'amoxicillin 1000 mg b.i.d for 2 weeks', 'armGroupLabels': ['Control group', 'Lactobacillus reuteri group']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'description': 'clarithromycin 500mg b.i.d for 2 weeks', 'armGroupLabels': ['Control group', 'Lactobacillus reuteri group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig University Hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'BioGaia AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Tropical Medicine and Hepatogastroenterology', 'investigatorFullName': 'Moahmed Hassan Emara', 'investigatorAffiliation': 'Zagazig University'}}}}