An observational study in Atopic Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 2 sites in Mali. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 288 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study participants will be recruited from the Bamako area
Inclusion Criteria (Study Group):
Inclusion Criteria (Healthy Volunteers):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Differences in gut microbiome between atopic patients and healthy controls in children and adults.
Shannon diversity index analyzed using t-test with significance level of .05, will be lower in patients with atopic disease.
Time frame: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the skin microbiome.
RNAseq
Time frame: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the gut microbiome.
Metagenomic sequencing
Time frame: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the nasal microbiome
Metagenomic sequencing
Time frame: Within 28 days after the screening visit.
Presence, frequency, and/or proximity to environmental exposures.
Patient survey to establish risk. Higher exposure, linked to higher atopy risk.
Time frame: Within 28 days after the screening visit.
Serum concentration of total IgE, specific IgE panels, and eosinophils
Time frame: Within 28 days after the screening visit.
Concentration of pollutants or pollutant biomarkers in urine and serum
Time frame: Within 28 days after the screening visit.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 364 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 97. This study's planned 15 months is below that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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National Institute of Allergy and Infectious Diseases (NIAID) →