Microbiome and Atopy in Mali
ConditionAtopic Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Clinical diagnosis of atopic disease, as defined by Hanifin and Rajka criteria, that has been present for ≥3 months before the screening visit.
Disqualifiers
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.
Trial population
Study participants will be recruited from the Bamako area
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
288 Participants
are grouped into 2 trial groupsGroup A: Participants with atopic disease (asthma or atopic dermatitis)
Group B: Age/sex-matched healthy volunteers.
Trial outcomes
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.
Time frame
Within 28 days after the screening visit.Secondary outcomes
1
Relative abundance of taxa and expression of metabolically functional genes in the skin microbiome.
RNAseq
Time frame
Within 28 days after the screening visit.2
Relative abundance of taxa and expression of metabolically functional genes in the gut microbiome.
Metagenomic sequencing
Time frame
Within 28 days after the screening visit.3
Relative abundance of taxa and expression of metabolically functional genes in the nasal microbiome
Metagenomic sequencing
Time frame
Within 28 days after the screening visit.4
Presence, frequency, and/or proximity to environmental exposures.
Patient survey to establish risk. Higher exposure, linked to higher atopy risk.
Time frame
Within 28 days after the screening visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov