Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-26 @ 7:00 PM
Study NCT ID:
NCT04213703
Status:
WITHDRAWN
Last Update Posted:
2025-06-05
First Post:
2019-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}, {'id': 'D016110', 'term': 'Epidermolysis Bullosa Simplex'}, {'id': 'D016108', 'term': 'Epidermolysis Bullosa Dystrophica'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company shifted focus', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2019-12-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing', 'timeFrame': 'Three years', 'description': 'Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with Epidermolysis Bullosa'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epidermolysis Bullosa', 'Epidermolysis Bullosa Simplex', 'Epidermolysis Bullosa Dystrophica']}, 'descriptionModule': {'briefSummary': 'This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.', 'detailedDescription': "The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Epidermolysis Bullosa"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been diagnosed with Epidermolysis Bullosa', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent\n2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)\n3. Diagnosis of Epidermolysis by at least one of the following i. Biopsy ii. Genetic testing\n\nExclusion Criteria:\n\n1. Refusal to sign informed consent form\n2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.\n3. Postoperative stoma, ostomy, or ileoanal pouch\n4. Participation in any experimental drug protocol within the past 12 weeks\n5. Treatment with total parenteral nutrition"}, 'identificationModule': {'nctId': 'NCT04213703', 'briefTitle': 'A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa', 'orgStudyIdInfo': {'id': 'PRG-034'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Epidermolysis Bullosa', 'description': 'Patients who have been diagnosed with Epidermolysis Bullosa', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There is no intervention for this study', 'armGroupLabels': ['Patients with Epidermolysis Bullosa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'ProgenaBiome', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Sabine Hazan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProgenaBiome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}