Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT05239403
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Gut Microbiome and Dietary Determinants and Vaccine Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between fecal microbiome diversity and seroconversion following influenza vaccination', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': "This study evaluates the association between gut microbiome and dietary determinants and vaccine response. This study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body's immune response to the influenza vaccine.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response.\n\nSECONDARY OBJECTIVE:\n\nI. To determine the gut microbial signatures and dietary patterns associated with response to influenza vaccination as measured by vaccine-specific post vaccine serum titers.\n\nEXPLORATORY OBJECTIVES:\n\nI. Interrogation of the overlap between the identified signature and excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts).\n\nII. Identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response.\n\nOUTLINE:\n\nParticipants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson employees', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. MD Anderson employees and student employees with existing MRN\n2. Must be able to donate blood\n3. Participants must be age 18 or older\n4. Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health\n5. Participants must consent to gut microbiome profiling, REDCap-based dietary screening questionnaire (Appendix A) and survey (Appendix B), and vaccine immune response testing which requires one stool sample, and two blood draws\n\nExclusion Criteria:\n\n1\\. Participants with a contraindication to the recommended annual influenza vaccine\n\nPregnant women may be included in this study.'}, 'identificationModule': {'nctId': 'NCT05239403', 'briefTitle': 'Association Between Gut Microbiome and Dietary Determinants and Vaccine Response', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response', 'orgStudyIdInfo': {'id': '2020-1054'}, 'secondaryIdInfos': [{'id': 'NCI-2021-09308', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2020-1054', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaire, biospecimen collection)', 'description': 'Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected'], 'description': 'Undergo collection of blood and stool samples', 'armGroupLabels': ['Observational (questionnaire, biospecimen collection)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (questionnaire, biospecimen collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Wargo, MD', 'role': 'CONTACT', 'email': 'jwargo@mdanderson.org', 'phone': '713-792-6940'}, {'name': 'Jennifer Wargo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jennifer Wargo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}