Microbes and allergic conditions in Mali

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lamissa05@gmail.com
• Phone: +223 66956944

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.