Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05618418
Status:
RECRUITING
Last Update Posted:
2022-11-16
First Post:
2022-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fecal samples collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival in patients with and without cytolysin producing E. faecalis in fecal samples', 'timeFrame': '6 months', 'description': 'Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)'}], 'secondaryOutcomes': [{'measure': 'Survival in patients with and without cytolysin producing E. faecalis in fecal samples', 'timeFrame': '1 year', 'description': 'Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)'}, {'measure': 'Survival in patients with and without cytolysin producing E. faecalis in fecal samples', 'timeFrame': '30 days', 'description': 'Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)'}, {'measure': 'Survival in patients with and without cytolysin producing E. faecalis in fecal samples', 'timeFrame': '90 days', 'description': 'Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut microbiome'], 'conditions': ['Alcoholic Hepatitis']}, 'descriptionModule': {'briefSummary': 'Alcoholic hepatitis is a disease with a high mortality rate with few treatment options improving survival. Recently certain bacterial strains has been correlated to survival in patients with alcoholic hepatitis.\n\nIn the BATTLE-trial the investigators will investigate if certain bacteria are correlated to decreased chance of survival in patients with alcoholic hepatitis.', 'detailedDescription': 'Patients with alcoholic hepatitis who are admitted to Copenhagen University Hospital Hvidovre and Herlev will be invited to participate.\n\nBlood and fecal samples following hospital admission will be collected. Through one-year follow-up correlation of certain bacteria in fecal samples with survival will be investigated.\n\nIn particular whether patients with cytolysin producing E. faecalis has a decreased chance of survival compared to patients without this bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital admitted patients with alcoholic hepatitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Bilirubin \\> 50 micromol/L\n* History of large alcoholic consumption in period prior to hospital admission (in the last six months)\n* No bile-duct obstruction (investigated through US, CT og MRI)\n\nExclusion Criteria:\n\n* Hepatocellulary carcinoma\n* Viral hepatitis\n* Autoimmune hepatitis\n* Portal vein thrombosis\n* Pregnancy\n* Expected survival for less than one year caused by other diseases (based on decision from project responsible doctors'}, 'identificationModule': {'nctId': 'NCT05618418', 'acronym': 'BATTLE', 'briefTitle': 'BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)', 'orgStudyIdInfo': {'id': 'H-21041462'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospital admitted patients with alcoholic hepatitis', 'description': 'Inclusion criteria:\n\nAge ≥ 18 Bilirubin \\> 50 micromol/L History of large alcoholic consumption in period prior to hospital admission (in the last six months) No bile-duct obstruction (investigated through US, CT og MRI)\n\nExclusion criteria:\n\nHepatocellulary carcinoma Viral hepatitis Autoimmune hepatitis Portal thrombosis Pregnancy Expected survival for less than one year caused by other diseases (based on decision from project responsible doctors)', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Hospital admitted patients with alcoholic hepatitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'frederik cold, MD, PHD', 'role': 'CONTACT', 'email': 'frederik.cold@regionh.dk', 'phone': '21157167'}], 'facility': 'Copenhagen University Hospital Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'frederik cold, MD, PHD', 'role': 'CONTACT', 'email': 'frederik.cold@regionh.dk', 'phone': '+4521157167'}], 'overallOfficials': [{'name': 'frederik cold, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital, Hvidovre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to make data available to researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, Ph.d., Specialist Registrar in Medical Gastroenterology', 'investigatorFullName': 'Frederik Cold', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}