Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 7:50 PM
Study NCT ID:
NCT01085760
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2010-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'talwalkar.jayant@mayo.edu', 'phone': '507-538--4877', 'title': 'Dr. Jayant A. Talwalkar', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'High Dose Metronidazole', 'description': 'metronidazole 500 mg 3 times a day', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'metallic taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'numbness and tingling of extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'burning in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day'}, {'id': 'OG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day'}, {'id': 'OG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day'}, {'id': 'OG003', 'title': 'High Dose Metronidazole', 'description': 'Metronidazole 500 mg 3 times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-117', 'groupId': 'OG000', 'lowerLimit': '-304', 'upperLimit': '165'}, {'value': '-49', 'groupId': 'OG001', 'lowerLimit': '-315', 'upperLimit': '18'}, {'value': '-62', 'groupId': 'OG002', 'lowerLimit': '-502', 'upperLimit': '212'}, {'value': '-36', 'groupId': 'OG003', 'lowerLimit': '-450', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 12 weeks', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants was based on a per protocol analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Bilirubin Following 12 Weeks Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day'}, {'id': 'OG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day'}, {'id': 'OG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day'}, {'id': 'OG003', 'title': 'High Dose Metronidazole', 'description': 'Metronidazole 500 mg 3 times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '0.2'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '9.7'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '0'}, {'value': '0.05', 'groupId': 'OG003', 'lowerLimit': '-0.5', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 12 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis done'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day'}, {'id': 'OG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day'}, {'id': 'OG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day'}, {'id': 'OG003', 'title': 'High Dose Metronidazole', 'description': 'Metronidazole 500 mg 3 times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'groupId': 'OG000', 'lowerLimit': '-1.13', 'upperLimit': '0.21'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.71', 'upperLimit': '1.15'}, {'value': '-0.26', 'groupId': 'OG002', 'lowerLimit': '-0.75', 'upperLimit': '0.09'}, {'value': '-0.20', 'groupId': 'OG003', 'lowerLimit': '-0.64', 'upperLimit': '0.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age \\[years\\]) + 0.54 Ln (total bilirubin \\[mg/dL\\]) + 0.54 Ln (AST \\[IU/L\\]) + 1.24 (variceal bleeding) - 0.84 (albumin \\[g/dL\\]). There is no range, minimum, or maximum value but greater values indicate worse disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day'}, {'id': 'OG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day'}, {'id': 'OG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day'}, {'id': 'OG003', 'title': 'High Dose Metronidazole', 'description': 'Metronidazole 500 mg 3 times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-47.3', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '28.6'}, {'value': '-3.6', 'groupId': 'OG002', 'lowerLimit': '-17.4', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-1.9', 'upperLimit': '2.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 12 weeks', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis done'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day'}, {'id': 'FG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day'}, {'id': 'FG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day'}, {'id': 'FG003', 'title': 'High Dose Metronidazole', 'description': 'metronidazole 500 mg 3 times a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 35 adult patients with primary sclerosing cholangitis (PSC) were enrolled between February 2010 and November 2011 at Mayo Clinic, Rochester MN.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose Vancomycin', 'description': 'Vancomycin 125 mg 4 times a day'}, {'id': 'BG001', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin 250 mg 4 times a day'}, {'id': 'BG002', 'title': 'Low Dose Metronidazole', 'description': 'Metronidazole 250 mg 3 times a day'}, {'id': 'BG003', 'title': 'High Dose Metronidazole', 'description': 'metronidazole 500 mg 3 times a day'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '70'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '64'}, {'value': '40', 'groupId': 'BG003', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '40', 'groupId': 'BG004', 'lowerLimit': '20', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-12', 'studyFirstSubmitDate': '2010-03-10', 'resultsFirstSubmitDate': '2012-11-02', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-12', 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment', 'timeFrame': 'baseline, 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Bilirubin Following 12 Weeks Treatment', 'timeFrame': 'baseline, 12 weeks'}, {'measure': 'Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment', 'timeFrame': 'baseline, 12 weeks', 'description': 'The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age \\[years\\]) + 0.54 Ln (total bilirubin \\[mg/dL\\]) + 0.54 Ln (AST \\[IU/L\\]) + 1.24 (variceal bleeding) - 0.84 (albumin \\[g/dL\\]). There is no range, minimum, or maximum value but greater values indicate worse disease.'}, {'measure': 'Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment', 'timeFrame': 'baseline, 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Sclerosing Cholangitis']}, 'referencesModule': {'references': [{'pmid': '23384404', 'type': 'DERIVED', 'citation': 'Tabibian JH, Weeding E, Jorgensen RA, Petz JL, Keach JC, Talwalkar JA, Lindor KD. Randomised clinical trial: vancomycin or metronidazole in patients with primary sclerosing cholangitis - a pilot study. Aliment Pharmacol Ther. 2013 Mar;37(6):604-12. doi: 10.1111/apt.12232. Epub 2013 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.', 'detailedDescription': 'In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. Each group will be treated for three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of PSC established by alkaline phosphatase \\>1.5 times and/or two fold elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.\n* Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.\n* Both genders.\n* Age ≥ 18 years old and \\< than 75 years old.\n* Patient's informed consent for study participation.\n\nExclusion Criteria:\n\n* Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three months.\n* Active drug or alcohol use.\n* Prior history of allergic reactions to the antibiotics which will be used in the study.\n* Any condition that, in the opinion of the investigator, would interfere with the patients' ability to complete the study safely or successfully.\n* Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy.\n* Anticipated need for transplantation in one year (Mayo survival model \\<80% one-year survival without transplant).\n* Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis.\n* Pregnancy or current lactation. Subjects becoming pregnant during the study will be withdrawn."}, 'identificationModule': {'nctId': 'NCT01085760', 'acronym': 'PSC', 'briefTitle': 'A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis', 'orgStudyIdInfo': {'id': '08-008247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vancomycin 125 mg orally 4 times a day', 'description': 'The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole.', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Vancomycin 250 mg orally 4 times a day', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Metronidazole 250 mg orally 3 times a day', 'interventionNames': ['Drug: Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Metronidazole 500 mg orally 3 times a day', 'interventionNames': ['Drug: Metronidazole']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Comparison of different doses of drug', 'armGroupLabels': ['Vancomycin 125 mg orally 4 times a day']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Comparison of different doses of drug', 'armGroupLabels': ['Vancomycin 250 mg orally 4 times a day']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': 'Comparison of different doses of drug', 'armGroupLabels': ['Metronidazole 250 mg orally 3 times a day']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': 'Comparison of different doses of drug', 'armGroupLabels': ['Metronidazole 500 mg orally 3 times a day']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Comparison of different drug doses', 'armGroupLabels': ['Vancomycin 125 mg orally 4 times a day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jayant A Talwalkar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'PSC Partners Seeking a Cure', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jayant A. Talwalkar', 'investigatorAffiliation': 'Mayo Clinic'}}}}