Microbes and allergic conditions in Mali

Analyzing the Microbiome and Environmental Exposures of Patients Suffering From Atopic Diseases in Mali

This study will try to see if differences in microbes on and in the body and in the local environment are linked to asthma, eczema, or other allergic conditions in people in Bamako, Mali.

Quick facts

• Study type: Observational
• Enrollment: 288 (estimated)
• Ages: 3 Years and up
• Sex: All
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Locations: 2 sites (Bamako and 1 other locations)
• Trial ID: NCT07051902 on ClinicalTrials.gov

What this trial studies

This case-control study will recruit people with physician-diagnosed atopic dermatitis or asthma and sex- and age-matched healthy controls from Bamako, Mali. Participants will have clinical evaluations, pulmonary function testing, transepidermal electrical impedance measurement, and an interviewer-administered environmental exposure questionnaire. Investigators will collect skin and nasal swabs, induced sputum when possible, blood, stool, drinking water samples, and community air samples to profile microbial communities and pollutant exposures. The study will compare microbiome diversity and environmental pollutant patterns between cases and controls and examine temporal and spatial variation in exposures.

Who should consider this trial

Good fit: Ideal candidates are people aged 3 years and older in Bamako who either have physician-diagnosed atopic dermatitis or asthma for at least three months, or are age- and sex-matched healthy volunteers without allergic disease and able to provide informed consent (or parental consent for minors).

Not a fit: People living outside the recruitment area, those unable or unwilling to provide biological or environmental samples or complete testing, and individuals whose symptoms are due to non-atopic conditions are unlikely to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the findings could identify microbial or environmental factors linked to allergic diseases that inform prevention strategies or targeted interventions in similar settings.

How similar studies have performed: Previous studies have found associations between microbiome patterns and allergic diseases in other populations, but causality remains unclear and data from West Africa are limited.

Eligibility criteria

Inclusion Criteria (Study Group):

* Aged ≥3 years.
* 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).
* Positive Screening questionnaire for asthma or eczema.
* Diagnosed with atopic dermatitis or asthma via physician diagnosis and criteria as follows:
* Clinical diagnosis of atopic disease, as defined by Hanifin and Rajka criteria, that has been present for ≥3 months before the screening visit.

Inclusion Criteria (Healthy Volunteers):

* Aged ≥3 years.
* 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).
* Negative Screening questionnaire for asthma and eczema.
* In good general health as evidenced by medical history and not diagnosed with atopic dermatitis or asthma via physician diagnosis.
* Failure to meet Hanifin and Rajka criteria and \<3 on GINA guidelines for asthma diagnosis.
* No self-reported history of food allergy.

Exclusion Criteria:

* Use of antibiotics in the 3 months prior to screening.
* Current pregnancy or lactation (determined by self-report).
* Treatment with an investigational drug within 12 months prior to screening.
* Current smoker or tobacco use within 4 months prior to screening.
* Current skin infections other than atopic dermatitis (e.g., scabies).
* Active diarrhea as defined by three or more loose stools per day (Bristol stool scale score of 6 or 7).
* Presence of current bacterial, viral, or fungal infection, with the exception of isolated onchomycosis, which is not exclusionary.
* Any other condition or factor that the investigator determines may significantly influence the results of testing.

Where this trial is running

Bamako and 1 other locations

• Dermatology Hospital of Bamako — Bamako, Mali (Recruiting)
• Pneumology Ward, Point G University Hospital — Bamako, Mali (Recruiting)

Study contacts

• Principal investigator: Ian Myles, MD — NIAID, National Institutes of Health (NIH)
• Study coordinator: Cisse Lamissa, MD

Conditions Atopic Disease; asthma; atopic dermatitis; allergies