Microbiome and Atopy in Mali (NCT07051902) | Clinical Trial Compass
RecruitingNot Applicable
Microbiome and Atopy in Mali
Mali288 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in gut microbiome between atopic patients and healthy controls in children and adults.
Timeframe: Within 28 days after the screening visit.
Trial details
NCT IDNCT07051902
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)