Trials / Recruiting
RecruitingNCT07051902
Microbiome and Atopy in Mali
Analyzing the Microbiome and Environmental Exposures of Patients Suffering From Atopic Diseases in Mali
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 288 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Accepted
Summary
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, the investigators will look for clues about things that may affect whether people get allergic diseases. The investigators will look at things on or in the body, like germs, and things in the environment, like pollution. To do this, the investigators will collect different types of biological samples, health information, and environmental information from people with allergic diseases and people without allergic diseases. The investigators will compare what is found in each group to look for differences that might be related to allergic disease.
Detailed description
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.
Conditions
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-07-04
- Last updated
- 2026-04-15
Locations
2 sites across 1 country: Mali
Source: ClinicalTrials.gov record NCT07051902. Inclusion in this directory is not an endorsement.