Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT07051902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbiome and Atopy in Mali
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Skin swabs, nasal swabs, sputum, whole blood, stool, urine, skin tape strip'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in gut microbiome between atopic patients and healthy controls in children and adults.', 'timeFrame': 'Within 28 days after the screening visit.', 'description': 'Shannon diversity index analyzed using t-test with significance level of .05.'}], 'secondaryOutcomes': [{'measure': 'Relative abundance of taxa and expression of metabolically functional genes in the skin microbiome.', 'timeFrame': 'Within 28 days after the screening visit.', 'description': 'RNAseq'}, {'measure': 'Relative abundance of taxa and expression of metabolically functional genes in the gut microbiome.', 'timeFrame': 'Within 28 days after the screening visit.', 'description': 'Metagenomic sequencing'}, {'measure': 'Relative abundance of taxa and expression of metabolically functional genes in the nasal microbiome', 'timeFrame': 'Within 28 days after the screening visit.', 'description': 'Metagenomic sequencing'}, {'measure': 'Presence, frequency, and/or proximity to environmental exposures.', 'timeFrame': 'Within 28 days after the screening visit.', 'description': 'Patient survey'}, {'measure': 'Serum concentration of total IgE, specific IgE panels, and eosinophils', 'timeFrame': 'Within 28 days after the screening visit.'}, {'measure': 'Concentration of pollutants or pollutant biomarkers in urine and serum', 'timeFrame': 'Within 28 days after the screening visit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'atopic dermatitis', 'allergies'], 'conditions': ['Atopic Disease']}, 'descriptionModule': {'briefSummary': 'This study is about allergic diseases in people living in Mali. Allergic diseases can cause health problems like asthma or skin rashes. In this study, we will look for clues about things that may affect whether people get allergic diseases. We will look at things on or in the body, like germs, and things in the environment, like pollution. To do this, we will collect different types of biological samples, health information, and environmental information from people with allergic diseases and people without allergic diseases. We will compare what we find in each group to look for differences that might be related to allergic disease.', 'detailedDescription': 'This is a case-control study where participants from Bamako in Mali will be screened to identify patients with atopic disease (asthma and atopic dermatitis). Age and sex-matched healthy controls will be selected at a 1:1 ratio. All study participants (including healthy controls) will undergo a clinical evaluation and provide skin swabs, nasal swabs, induced sputum (if successful), blood samples, drinking water samples, stool samples, as well as complete an interviewer-administered questionnaire on environmental exposures. All participants (including healthy controls) will also undergo pulmonary function testing (spirometry and/or oscillometry) and undergo testing of transepidermal electrical impedance (using a Nevisense machine). Samples will be used to evaluate the microbiome diversity in participants with allergy-related diseases (ARDs) compared to healthy controls. Environmental surveys will assess the association between atopy and exposures that are primarily outdoor versus indoor exposures. Temporal and spatial variation in these pollutants will be assessed. Air samples taken from the community and participant home drinking water samples (when available) will be used to assess the presence and variability of pollutants in the environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be recruited from the Bamako area', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Study Group):\n\n* Aged ≥3 years.\n* Able to provide informed consent (for ages ≥18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \\<18 years).\n* Positive Screening questionnaire for asthma or eczema.\n* Diagnosed with atopic dermatitis or asthma via physician diagnosis and criteria as follows:\n* Clinical diagnosis of atopic disease, as defined by Hanifin and Rajka criteria, that has been present for ≥3 months before the screening visit.\n\nInclusion Criteria (Healthy Volunteers):\n\n* Aged ≥3 years.\n* Able to provide informed consent (for ages ≥18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \\<18 years).\n* Negative Screening questionnaire for asthma and eczema.\n* In good general health as evidenced by medical history and not diagnosed with atopic dermatitis or asthma via physician diagnosis.\n* Failure to meet Hanifin and Rajka criteria and \\<3 on GINA guidelines for asthma diagnosis.\n* No self-reported history of food allergy.\n\nExclusion Criteria:\n\n* Use of antibiotics in the 3 months prior to screening.\n* Current pregnancy or lactation (determined by self-report).\n* Treatment with an investigational drug within 12 months prior to screening.\n* Current smoker or tobacco use within 4 months prior to screening.\n* Current skin infections other than atopic dermatitis (e.g., scabies).\n* Active diarrhea as defined by three or more loose stools per day (Bristol stool scale score of 6 or 7).\n* Presence of current bacterial, viral, or fungal infection, with the exception of isolated onchomycosis, which is not exclusionary.\n* Any other condition or factor that the investigator determines may significantly influence the results of testing.'}, 'identificationModule': {'nctId': 'NCT07051902', 'briefTitle': 'Microbiome and Atopy in Mali', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Analyzing the Microbiome and Environmental Exposures of Patients Suffering From Atopic Diseases in Mali', 'orgStudyIdInfo': {'id': 'Microbiome in Mali'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with atopic disease (asthma or atopic dermatitis)'}, {'label': 'Age/sex-matched healthy volunteers.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bamako', 'country': 'Mali', 'contacts': [{'name': 'Cisse Lamissa, MD', 'role': 'CONTACT', 'email': 'lamissa05@gmail.com', 'phone': '+223 66956944'}], 'facility': 'Dermatology Hospital of Bamako', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'city': 'Bamako', 'country': 'Mali', 'contacts': [{'name': 'Khadida Ouattara, MD, M.Sc.', 'role': 'CONTACT', 'email': 'zankhadi@gmail.com', 'phone': '+223 66780357'}], 'facility': 'Pneumology Ward, Point G University Hospital', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}], 'centralContacts': [{'name': 'Cisse Lamissa, MD', 'role': 'CONTACT', 'email': 'lamissa05@gmail.com', 'phone': '+223 66956944'}, {'name': 'Khadida Ouattara, MD, MSc', 'role': 'CONTACT', 'email': 'zankhadi@gmail.com', 'phone': '+223 66780357'}], 'overallOfficials': [{'name': 'Nadia Shobnam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LCIM, NIAID, NIH'}, {'name': 'Ian Myles', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}