Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-21 @ 4:05 PM
Study NCT ID:
NCT04031469
Status:
SUSPENDED
Last Update Posted:
2025-07-31
First Post:
2019-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D020852', 'term': 'Lyme Neuroborreliosis'}, {'id': 'D000077342', 'term': 'Post-Lyme Disease Syndrome'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D003193', 'term': 'Compulsive Personality Disorder'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004820', 'term': 'Epidermolysis Bullosa'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D006073', 'term': 'Gout'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Administrative', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing', 'timeFrame': 'One year', '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 among specific gastrointestinal disease types.'}], 'secondaryOutcomes': [{'measure': 'Validation of Sequencing Methods', 'timeFrame': 'One year', 'description': 'To validate the methods used to sequence samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'autism', 'ASD', 'Myalgic encephalomyelitis', 'ME/CFS', 'Psoriasis', 'Chronic UTI', 'Chronic Urinary Tract Infection', 'Ulcerative Colitis', 'UC', 'Multiple Sclerosis', 'MS', 'Chronic Constipation', 'Constipation', 'Celiac disease', 'Celic Sprue', 'Lyme disease', 'Elevated Cholesterol', 'Colorectal Cancer', 'Cancer', 'Amyotrophic Lateral Sclerosis', 'ALS', 'Rheumatoid Arthritis', 'RA', 'Chronic Fatigue', 'Alzheimer disease', 'Chrohns colitis', 'Crohn', 'Alzheimer', 'Parkinson', 'depression', 'major depressive disorder', 'OCD', 'Obsessive-Compulsive disorder', 'Biopolar', 'Bipolar disorder', 'Migraine', 'Migraine headache', 'Diabetes', 'DM', 'Diabetes DM', 'Lupus', 'Lupus eruthematosus', 'Epidermolysis Bullosa', 'Mesothelioma', 'IBS', 'Irritable Bowel Syndrome', 'Eczema', 'Acne', 'Myasthenia Gravis', 'Gout'], 'conditions': ['Gut Microbiome', 'Gastrointestinal Microbiome', 'Autism', 'Autism Spectrum Disorder', 'Autism Spectrum Disorder High-Functioning', 'Alzheimer Disease', 'Alzheimer Dementia (AD)', 'Alzheimer Dementia', 'Alzheimer Disease (AD)', 'Crohn', 'Crohn Colitis', 'Crohn Disease (CD)', 'Crohn Disease Colon', 'Myalgic Encephalomyelitis', 'ME/CFS', 'Myalgic Encephalomyelitis (ME)', 'Myalgic Encephalomyelitis/Chronic Fatigue Syndrome', 'Psoriasis', 'Psoriasis Annularis', 'Psoriasis Chronic', 'Chronic Urinary Tract Infection', 'Ulcerative Colitis (Disorder)', 'Ulcerative Colitis (UC)', 'Ulcerative Colitis Acute', 'Ulcerative Colitis Chronic', 'Multiple Sclerosis', 'Multiple Sclerosis (MS) - Relapsing-remitting', 'Multiple Sclerosis (MS) Primary Progressive', 'Constipation Chronic Idiopathic', 'Constipation', 'Celiac', 'Celiac Disease', 'Celiac Sprue', 'Lyme Arthritis', 'Lyme Borreliosis, Nervous System', 'Lyme Disease, Chronic', 'Cholesterol', 'Cholesterol Level, High', 'Cancer', 'Colon Cancer', 'Amyotrophic Lateral Sclerosis (ALS)', 'Amyotrophic Lateral Sclerosis', 'Rheumatoid Arthritis (RA)', 'Rheumatoid Arthritis - Rheumatism', 'Chronic Fatigue Syndrome (CFS)', 'PARKINSON DISEASE (Disorder)', 'Parkinson Disease', 'Parkinson Disease (PD)', 'Depression', 'Major Depressive Disorder (MDD)', 'Depression Disorder', 'Depression in Adults', 'Anxiety', 'Anxiety Disorder Generalized', 'Obsessive Compulsive Disorder (OCD)', 'Obsessive Compulsive Disorder OCD', 'Obsessive - Compulsive Disorder', 'Bipolar', 'Bipolar 1 Disorder', 'Bipolar Disorder (BD)', 'Bipolar Disorder I and II', 'Bipolar and Related Disorders', 'Migraine', 'Migraine Disorder', 'Diabetes (DM)', 'Diabetes', 'Lupus', 'Lupus Erythematosus', 'Epidermolysis Bullosa (EB)', 'Mesothelioma', 'Mesothelioma Malignant', 'IBS (Irritable Bowel Syndrome)', 'Irritable Bowel', 'IBS - Irritable Bowel Syndrome', 'Irritable Bowel Syndrome (IBS)', 'Eczema', 'Eczema Atopic Dermatitis', 'Acne', 'Myasthaenia Gravis', 'Gout']}, 'referencesModule': {'references': [{'pmid': '35483736', 'type': 'DERIVED', 'citation': 'Hazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. BMJ Open Gastroenterol. 2022 Apr;9(1):e000871. doi: 10.1136/bmjgast-2022-000871.'}]}, '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 the information provided in surveys and in medical records."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and minors of any age', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study\n* 2\\. Male or female patients of any age (interest is given to children to compare with mothers).\n\nExclusion Criteria:\n\n* 1\\. Refusal to sign informed consent form\n* 2\\. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.\n* 3\\. Postoperative stoma, ostomy, or ileoanal pouch\n* 4\\. Participation in any experimental drug protocol within the past 12 weeks\n* 5\\. Treatment with total parenteral nutrition\n* 6\\. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial\n* 7\\. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study"}, 'identificationModule': {'nctId': 'NCT04031469', 'briefTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease', 'organization': {'class': 'OTHER', 'fullName': 'ProgenaBiome'}, 'officialTitle': 'A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease', 'orgStudyIdInfo': {'id': 'PRG-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Population', 'description': 'The general population will have their microbiome sequenced from stool samples provided.', 'interventionNames': ['Other: There is no intervention in this study']}], 'interventions': [{'name': 'There is no intervention in this study', 'type': 'OTHER', 'description': 'There is no intervention in this study', 'armGroupLabels': ['General Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Sabine Hazan', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Sabine Hazan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ProgenaBiome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProgenaBiome', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}