Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-07 @ 10:57 PM
Study NCT ID:
NCT00751933
Status:
TERMINATED
Last Update Posted:
2015-04-28
First Post:
2008-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072772', 'term': 'Ty21a typhoid vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhat@helse-bergen.no', 'phone': '+47 55972900', 'title': 'Gunnar Nysæter or Solomon Tefera or Jan Hatlebakk', 'organization': 'Haukeland University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Arms', 'description': 'No adverse effects were recorded.', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom Score Improvement of 3 or More During or After 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'No patient completed the study, therefore we have no information to report.'}], 'timeFrame': '6 months', 'description': 'No patient completed the study, therefore we have no information to report.', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Score Improvement of 2 or More During or After 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'No patient completed the study, therefore we have no information to report.'}], 'timeFrame': '6 months', 'description': 'No patient completed the study, therefore we have no information to report.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaccine Arm 2', 'description': 'Vaccination with Vivotif and Dukoral\n\nVaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.'}, {'id': 'FG001', 'title': 'Oats Supplement 3', 'description': 'Dietary supplement with oats\n\nOats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.'}, {'id': 'FG002', 'title': 'Placebo 4', 'description': 'Placebo instead of vaccines No dietary supplement\n\nPlacebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine'}, {'id': 'FG003', 'title': 'Vaccine and Oats 1', 'description': 'Vaccination with Vivotif and Dukoral + dietary supplement with oats.\n\nVaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7.\n\nDukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.\n\nOne daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Arms', 'description': 'Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '41'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Lack of patients compatible with the protocol´s criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2008-09-11', 'resultsFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2008-09-11', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-10', 'studyFirstPostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Score Improvement of 3 or More During or After 6 Months', 'timeFrame': '6 months', 'description': 'No patient completed the study, therefore we have no information to report.'}], 'secondaryOutcomes': [{'measure': 'Symptom Score Improvement of 2 or More During or After 6 Months', 'timeFrame': '6 months', 'description': 'No patient completed the study, therefore we have no information to report.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulcerative colitis', 'Vaccines', 'Oats'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. The combined use of oral typhoid vaccine and cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. Or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ulcerative colitis of at least 4 months duration\n* disease activity index score (Walmsley) \\>5 and \\</=13\n* patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. They must remain on the same dose throughout the study (6 months).\n* stool examination negative for enteric pathogens, clostridium difficile toxin and parasites\n\nExclusion Criteria:\n\n* ulcerative colitis disease activity index \\>13\n* symptoms of bowel obstruction\n* other serious medical condition\n* use of any of the study vaccines during the last two years\n* use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period\n* pregnant or planning to become pregnant\n* breastfeeding\n* chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose\n* treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose\n* use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose'}, 'identificationModule': {'nctId': 'NCT00751933', 'briefTitle': 'Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis.', 'orgStudyIdInfo': {'id': '16816 NSD'}, 'secondaryIdInfos': [{'id': '2007-002415-88 (SLV/EudraCT)', 'type': 'OTHER', 'domain': 'Statens Legemiddelverk'}, {'id': '911305 (Helse Vest RHF)', 'type': 'OTHER', 'domain': 'Helse Vest RHF'}, {'id': '82/2007 (P REK Nord)', 'type': 'OTHER', 'domain': 'Regional Etisk Komite'}, {'id': '16816 (NSD)', 'type': 'OTHER', 'domain': 'Norsk Samfunnsvitenskapelig Datatjeneste'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Vaccination with Vivotif and Dukoral', 'interventionNames': ['Biological: Vaccine Vivotif + Vaccine Dukoral']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Dietary supplement with oats', 'interventionNames': ['Dietary Supplement: Oats']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo instead of vaccines No dietary supplement', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Vaccination with Vivotif and Dukoral + dietary supplement with oats.', 'interventionNames': ['Biological: Vaccine Vivotif + Vaccine Dukoral + oats']}], 'interventions': [{'name': 'Vaccine Vivotif + Vaccine Dukoral + oats', 'type': 'BIOLOGICAL', 'otherNames': ['Ty21a', 'Vibrio cholera O1 Ogawa, inactivated'], 'description': 'Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.\n\nOne daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.', 'armGroupLabels': ['1']}, {'name': 'Vaccine Vivotif + Vaccine Dukoral', 'type': 'BIOLOGICAL', 'otherNames': ['Ty21a', 'Vibrio cholera O1 Ogawa, inactivated'], 'description': 'Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.', 'armGroupLabels': ['2']}, {'name': 'Oats', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Department of Medicine, Haukeland Universtiy Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Gunnar Nysæter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine,Haukeland University Hospital, Bergen, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Vest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Gunnar Nysæter', 'investigatorAffiliation': 'Haukeland University Hospital'}}}}