Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-30 @ 10:30 PM
Study NCT ID:
NCT05800704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C. difficile relative abundance', 'timeFrame': 'at 1, 2 and 4 weeks after completion of antimicrobial treatment for CDI', 'description': 'any change of C. difficile relative abundance during the first four weeks after antimicrobial treatment for CDI.'}], 'secondaryOutcomes': [{'measure': 'Gut microbiota', 'timeFrame': 'at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI', 'description': 'Gut microbiota diversity and taxonomic composition'}, {'measure': 'Abundance of antibiotic diarrhea associated pathogens', 'timeFrame': 'at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI', 'description': 'Abundance of other pathogens that are involved in antibiotic associated diarrhea e.g. S. aureus and K. oxytoca'}, {'measure': 'C. difficile toxins', 'timeFrame': 'at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI', 'description': 'Presence and amount of C. difficile toxins'}, {'measure': 'Toxin forming C. difficile strains', 'timeFrame': 'at 1, 2, 4 and 8 weeks after completion of antimicrobial treatment for CDI', 'description': 'Presence of toxin forming C. difficile strains'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut microbiota', 'Colonization resistance', 'Gut microbiota dysbiosis'], 'conditions': ['C. Difficile Enteritis']}, 'descriptionModule': {'briefSummary': 'Double blind, placebo-controlled, parallel, multicentric trial to investigat whether Nagasin® can support the colonization resistance against C.difficile.', 'detailedDescription': 'The aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement Nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment.\n\nThe main question is whether Nagasin® can prevent any increase in abundance of C.difficile within the first four weeks after antimicrobial treatment for a C. difficile infection.\n\nParticipants will receive Nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a C. difficile episode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* C. difficile infection (CDI) diagnosis\n* antimicrobial treatment (e.g. metronidazole, vancomycin or fidaxomicin) for C. difficile infection at ICF\n* Written informed consent by the participant after information about the research project\n\nExclusion Criteria:\n\n* total parenteral nutrition\n* insulin-dependent (type 1) diabetes\n* severe disease defined as any of the following:\n\n * White blood cell count (WBC) \\> 30,000 or \\< 1000 cells/mm3\n * Neutropenia \\< 500 x 10\\^9 per liter\n * Intensive care unit (ICU) patient at time C. difficile infection diagnosed\n * In case no hematology values are available, presence of severe can be evaluated by the local principal investigator or his designee\n* is severely immunocompromised as defined by any of the following:\n\n * active malignancy receiving severe immunosuppressive chemotherapy with subsequent leukopenia (as defined above)\n * long-term systemic steroid therapy ≥ 30 mg / d\n * recipients of stem cell transfer (≤ 12 months)\n * severe inborn immune deficiency or severe immunosuppressive therapy as evaluated by the investigator\n * HIV patients with low CD4+ cell count (\\< 200 x 10\\^9 per liter)\n * Inflammatory bowel disease patients if:\n * severe ulcerative colitis (classified as endoscopic Mayo = 3 (max. 30 days old) or as evaluated by investigator)\n * Severe Crohn's disease with acute penetrating complication (abscess and/or actively draining fistulae) or as evaluated by investigator\n * Liver cirrhosis (classified as Child C) with clinically significant portal hypertension and/or low thrombocyte count (20 × 10\\^9 per liter)\n* Acute pancreatitis\n* prosthetic heart valves or endocarditis\n* consumption of other high-dose (\\>10\\^10 cfu/dose) probiotic products during the study period.\n* Inability to understand and follow study procedures\n* prosthetic heart valves or endocarditis\n* consumption of other high-dose (\\>10\\^10 cfu/dose) probiotic products during the study period.\n* Inability to understand and follow study procedures"}, 'identificationModule': {'nctId': 'NCT05800704', 'briefTitle': 'Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Randomized, Controlled, Double-blind, Parallel, Multicentric Study to Investigate Support of the Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin® After Disturbance by Antimicrobial Treatment', 'orgStudyIdInfo': {'id': 'BASEC 2022-01318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nagasin®', 'description': 'consumption of Nagasin® (synbiotic food supplement) once per day for four weeks', 'interventionNames': ['Dietary Supplement: Nagasin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Comparator', 'description': 'consumption of the comparator (maltodextrin) once per day for four weeks', 'interventionNames': ['Dietary Supplement: maltodextrin']}], 'interventions': [{'name': 'Nagasin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus, Lactococcus and Bifidobacteria strains with antimicrobial effect against C. difficile', 'armGroupLabels': ['Nagasin®']}, {'name': 'maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'maltodextrin (placebo comparator)', 'armGroupLabels': ['Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}, {'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '6000', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '8400', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '8063', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Isabelle M Frey-Wagner, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University or Zurich, Institute of Medical Microbiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'Stadtspital Zürich', 'class': 'OTHER'}, {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, {'name': 'Cantonal Hosptal, Baselland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}