Atopic DiseaseNCT07051902
Microbiome and Atopy in Mali
An observational study of Atopic Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Disease
- How many people
- 288 participants
- Where
- 2 sitesMali
- Study dates
- 30 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants will be recruited from the Bamako area
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mali2 sites, 2 recruiting
- Recruiting
Dermatology Hospital of Bamako
Bamako
Cisse Lamissa, MD, +223 66956944, lamissa05@gmail.com
- Recruiting
Pneumology Ward, Point G University Hospital
Bamako
Khadida Ouattara, MD, M.Sc., +223 66780357, zankhadi@gmail.com
About this study
Official title: Analyzing the Microbiome and Environmental Exposures of Patients Suffering From Atopic Diseases in Mali
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.
Read the 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
- Keywords
- asthma, atopic dermatitis, allergies
- Medical subject headings
- Asthma, Dermatitis, Atopic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with atopic disease (asthma or atopic dermatitis) | Not described | |
| Age/sex-matched healthy volunteers. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 28 days after the screening visit.
Secondary outcomes (6)
Relative abundance of taxa and expression of metabolically functional genes in the skin microbiome.
RNAseq
Measured: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the gut microbiome.
Metagenomic sequencing
Measured: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the nasal microbiome
Metagenomic sequencing
Measured: Within 28 days after the screening visit.
Presence, frequency, and/or proximity to environmental exposures.
Patient survey to establish risk. Higher exposure, linked to higher atopy risk.
Measured: Within 28 days after the screening visit.
Serum concentration of total IgE, specific IgE panels, and eosinophils
Measured: Within 28 days after the screening visit.
Concentration of pollutants or pollutant biomarkers in urine and serum
Measured: Within 28 days after the screening visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start30 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ian Myles, MD, Principal investigator, NIAID, National Institutes of Health (NIH)Kingsley Osei-Karikari, Study chair, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051902
- Sponsor's protocol ID
- Microbiome in Mali
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Microbiome and Environmental Exposures of Patients Suffering From Atopic Diseases in Mali
- ClinicalTrials.gov ID
- NCT07051902
- Acronym / sponsor ID
- Microbiome in Mali
- Conditions
- Atopic Disease
- Keywords
- asthma, atopic dermatitis, allergies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with atopic disease (asthma or atopic dermatitis) | – | – |
| Age/sex-matched healthy volunteers. | – | – |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be recruited from the Bamako area
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in gut microbiome between atopic patients and healthy controls in children and adults.
Time frame: Within 28 days after the screening visit.
Shannon diversity index analyzed using t-test with significance level of .05, will be lower in patients with atopic disease.
6 secondary outcomes
Relative abundance of taxa and expression of metabolically functional genes in the skin microbiome.
Time frame: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the gut microbiome.
Time frame: Within 28 days after the screening visit.
Relative abundance of taxa and expression of metabolically functional genes in the nasal microbiome
Time frame: Within 28 days after the screening visit.
Presence, frequency, and/or proximity to environmental exposures.
Time frame: Within 28 days after the screening visit.
Serum concentration of total IgE, specific IgE panels, and eosinophils
Time frame: Within 28 days after the screening visit.
Concentration of pollutants or pollutant biomarkers in urine and serum
Time frame: Within 28 days after the screening visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Myles, MD principal investigator
NIAID, National Institutes of Health (NIH)
Kingsley Osei-Karikari study chair
National Institutes of Health (NIH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cisse Lamissa, MD (+223 66956944, lamissa05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in gut microbiome between atopic patients and healthy controls in children and adults. (time frame: Within 28 days after the screening visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.