Microbiome and Atopy in Mali

NCT ID: NCT07051902

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 288 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-08-31

Brief 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, we will look for clues about things that may affect whether people get allergic diseases. We will look at things on or in the body, like germs, and things in the environment, like pollution. To do this, we will collect different types of biological samples, health information, and environmental information from people with allergic diseases and people without allergic diseases. We will compare what we find 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

Atopic Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with atopic disease (asthma or atopic dermatitis)

No interventions assigned to this group

Age/sex-matched healthy volunteers.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Shobnam, MD

Role: PRINCIPAL_INVESTIGATOR

LCIM, NIAID, NIH

Ian Myles

Role: STUDY_CHAIR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Dermatology Hospital of Bamako

Bamako, , Mali

Pneumology Ward, Point G University Hospital

Bamako, , Mali

Countries

Mali

Central Contacts

Cisse Lamissa, MD

Role: CONTACT

lamissa05@gmail.com

+223 66956944

Khadida Ouattara, MD, MSc

Role: CONTACT

zankhadi@gmail.com

+223 66780357

Facility Contacts

Cisse Lamissa, MD

Role: primary

lamissa05@gmail.com

+223 66956944

Khadida Ouattara, MD, M.Sc.

Role: primary

zankhadi@gmail.com

+223 66780357

Other Identifiers

Microbiome in Mali

Identifier Type: -

Identifier Source: org_study_id