Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05584735
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2022-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Saliva, and Fecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influenza or COVID-17 antibody concentrations', 'timeFrame': 'Baseline', 'description': "Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2."}, {'measure': 'Influenza or COVID-19 antibody concentrations', 'timeFrame': 'One blood draw between 28-65 days after baseline', 'description': "Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2."}, {'measure': 'Microbiome metrics', 'timeFrame': 'One stool collection between days 0-65', 'description': 'Microbiome metrics will include phylogenetic diversity, and analyses of relative abundance of microbes using 16SrRNA gene sequence data from fecal material. Alpha diversity of the microbiome will be evaluated.'}, {'measure': 'Microbiome stability', 'timeFrame': 'One stool collection between days 0-65', 'description': 'Microbiome stability will be evaluated using hierarchical clustering of weighted and unweighted UniFrac distances (a beta diversity metric indexing compositional similarity/difference) for microbiome using 16SrRNA gene sequence data from fecal material.'}], 'secondaryOutcomes': [{'measure': 'Correlation between Fecal Metabolomic Activity and Vaccine Response', 'timeFrame': 'up to 65 days'}, {'measure': 'Correlation between Saliva DNA and Vaccine Response', 'timeFrame': 'up to 65 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'ulcerative colitis'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.', 'detailedDescription': 'The overall objective of this study is to evaluate the role of gut microbiome in influenza or COVID-19 vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to vaccines.\n\nIt is known that patients with IBD have dysbiosis of their gut microbiome and those immunosuppressed may have a lower vaccine response. In this aim, the investigators will evaluate whether differences in microbial diversity predict immune response to the influenza and COVID-19 vaccine.\n\nIn this prospective study, immunosuppressed IBD patients will be vaccinated per standard of care and blood will be collected to measure the immune response. A fecal and saliva sample will be collected to characterize the gut microbiome. The investigators hypothesize that reduced richness / alpha-diversity in gut microbiota will correlate with those with a blunted vaccine response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with IBD', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria\n* Currently one of the following groups:\n\n 1. Group A: Anti-TNF Therapy Group\n\n * Maintenance monotherapy: infliximab (at least every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)\n * Combination Therapy: Anti-TNF Combination Therapy Group on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP\n 2. Group B: Non-TNG biologic\n\n * Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP\n * Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP\n * Risankizumab Therapy: 360mg at least every 8 weeks\n 3. Group C: Janus Kinase Therapy\n\n * Tofacitinib Therapy: at least 5mg PO BID\n * Upadactinib Therapy: at least 15mg PO daily\n* Patient has been on stable treatment for IBD for at least three months\n* Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.\n\nExclusion Criteria:\n\n* Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)\n* Recent oral antibiotics within previous 2 months"}, 'identificationModule': {'nctId': 'NCT05584735', 'briefTitle': 'Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '2021-0977'}, 'secondaryIdInfos': [{'id': 'A534250', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE/GASTROENT', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol version 7/18/2024', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Inflammatory Bowel Disease (IBD)', 'description': 'Participants with IBD who are receiving a flu or COVID-19 vaccine', 'interventionNames': ['Biological: Influenza vaccine', 'Biological: COVID-19 vaccine']}], 'interventions': [{'name': 'Influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Observe effects of flu vaccine on microbiome', 'armGroupLabels': ['Participants with Inflammatory Bowel Disease (IBD)']}, {'name': 'COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': 'Observe effects of COVID-19 vaccine on microbiome', 'armGroupLabels': ['Participants with Inflammatory Bowel Disease (IBD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Freddy Caldera, DO, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}