Microbiome and Atopy in Mali

NCT07051902 | Recruiting

• 1 other identifier: Microbiome in Mali
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 2

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, 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.

Conditions

Atopic Disease

Keywords

asthma; atopic dermatitis; allergies

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 28 days after the screening visit.

Secondary Outcomes (6)

• Relative abundance of taxa and expression of metabolically functional genes in the skin microbiome.

  Within 28 days after the screening visit.

• Relative abundance of taxa and expression of metabolically functional genes in the gut microbiome.

  Within 28 days after the screening visit.

• Relative abundance of taxa and expression of metabolically functional genes in the nasal microbiome

  Within 28 days after the screening visit.

• Presence, frequency, and/or proximity to environmental exposures.

  Within 28 days after the screening visit.

• Serum concentration of total IgE, specific IgE panels, and eosinophils

  Within 28 days after the screening visit.

Study Arms (2)

Participants with atopic disease (asthma or atopic dermatitis)

Age/sex-matched healthy volunteers.

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from the Bamako area

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Any other condition or factor that the investigator determines may significantly influence the results of testing.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Dermatology Hospital of Bamako

Bamako, Mali

RECRUITING

Pneumology Ward, Point G University Hospital

Bamako, Mali

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Skin swabs, nasal swabs, sputum, whole blood, stool, urine, skin tape strip

MeSH Terms

Conditions

Asthma; Dermatitis, Atopic; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Ian Myles, MD

  NIAID, National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

• Kingsley Osei-Karikari

  National Institutes of Health (NIH)

  STUDY CHAIR

Central Study Contacts

Cisse Lamissa, MD

CONTACT

+223 66956944; lamissa05@gmail.com

Khadida Ouattara, MD, MSc

CONTACT

+223 66780357; zankhadi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

MA (2)