Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT01781312
Status:
UNKNOWN
Last Update Posted:
2013-01-31
First Post:
2013-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Probiotics in IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-29', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '3 months and 5 months'}], 'primaryOutcomes': [{'measure': 'Change in albuminuria', 'timeFrame': 'Baseline and 3 months'}], 'secondaryOutcomes': [{'measure': 'Change in renal function', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Change in IgA/IgG immune complexes', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Change in hematuria', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Change in immunological markers in blood', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Change in IBS (irritable bowel syndrome) symptoms', 'timeFrame': 'Baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy']}, 'descriptionModule': {'briefSummary': 'Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years\n* Primary IgAN, verified by biopsy\n* Albuminuria \\> 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion)\n* Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion)\n* Having signed informed consent form\n\nExclusion Criteria:\n\n* Participation in another clinical intervention trial\n* Patients with celiac disease\n* Patients with secondary IgAN\n* Creatinine clearance below 30 ml/min (mean of 3 measurements)\n* Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion\n* Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months\n* Patients using probiotic products within the last three months (includes probiotic milk products)\n* Known allergy or intolerance to any of the ingredients in the probiotic product'}, 'identificationModule': {'nctId': 'NCT01781312', 'briefTitle': 'Probiotics in IgA Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients', 'orgStudyIdInfo': {'id': 'SMR-2712'}, 'secondaryIdInfos': [{'id': 'SMR-2712', 'type': 'OTHER', 'domain': 'Protocol writer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ProTectis', 'interventionNames': ['Dietary Supplement: ProTectis']}, {'type': 'EXPERIMENTAL', 'label': 'Gastrus', 'interventionNames': ['Dietary Supplement: Gastrus']}], 'interventions': [{'name': 'ProTectis', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['ProTectis']}, {'name': 'Gastrus', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Gastrus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'contacts': [{'name': 'Anders Fernström, MD PhD', 'role': 'CONTACT'}, {'name': 'Anders Fernström, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Stockholm', 'country': 'Sweden', 'contacts': [{'name': 'Sigrid Lundberg, MD PhD', 'role': 'CONTACT'}, {'name': 'Sigrid Lundberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'contacts': [{'name': 'Bengt Fellström, MD PhD', 'role': 'CONTACT'}, {'name': 'Bengt Fellström, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uppsala University Hosptial', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Bengt Fellström, MD PhD', 'role': 'CONTACT', 'email': 'bengt.fellstrom@medsci.uu.se'}, {'name': 'Hilde K Smerud, PhD', 'role': 'CONTACT', 'email': 'hilde.smerud@medsci.uu.se'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Scientist', 'investigatorFullName': 'Hilde Kloster Smerud', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}