Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 5:32 PM
Study NCT ID:
NCT07223606
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2025-11-03
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplant for Neuroblastoma in a Single Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-10-31', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['FMT', 'fecal transplant', 'fecal microbiota transplant', 'microbiome', 'dysbiosis'], 'conditions': ['Neuroblastoma', 'Neuroblastoma (NB)', 'Neuroblastoma (NBL)', 'Neuroblastoma (Measurable Disease)', 'Neuroblastoma Recurrent', 'Neuroblastoma in Children', 'Neuroblastoma. CNS']}, 'descriptionModule': {'briefSummary': 'This study uses fecal microbiota transplant (FMT) to correct gut microbiome dysbiosis prior to and during standard-of-care neuroblastoma treatment', 'detailedDescription': 'Patients with neurobastoma and concurrent dysbiosis showing a bifidobacteria-bacteroides gap will undergo fecal microbiota transplant as an adjunctive to standard-of-care oncology treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willingness of parent/guardian to sign ICF\n* diagnosis of neuroblastoma\n* dysbiosis of the gut microbiome\n\nExclusion Criteria:\n\n* parent/guardian unwilling to sign ICF\n* dysbiosis does not show a bifidobaceteria-bacteroides gap\n* severely abnormal screening lab values'}, 'identificationModule': {'nctId': 'NCT07223606', 'briefTitle': 'Fecal Microbiota Transplant for Neuroblastoma in a Single Patient', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'Fecal Microbiota Transplant for Neuroblastoma in a Single Patient', 'orgStudyIdInfo': {'id': 'IND 31935'}, 'secondaryIdInfos': [{'id': 'IND 31935', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fecal Microbial Transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['FMT'], 'description': 'This study will utilize donor stool from an infant'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'ProgenaBiome', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'collaborators': [{'name': 'Microbiome Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}