Microbiome and Atopy in Mali
Recruiting · NCT07051902 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
4 locations listed.
- Dermatology Hospital of Bamako - Bamako, Mali
- Pneumology Ward, Point G University Hospital - Bamako, Mali
- Dermatology Hospital of Bamako - Bamako, Mali
- Pneumology Ward, Point G University Hospital - Bamako, Mali