Single Ascending and Multiple Ascending Dose Study of LCA-0061
NCT07701954
Atopic Disease, Food Hypersensitivity
Mississauga, Ontario, Canada
View Trial DetailsNCT Number: NCT07051902
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.
Interested in participating?
Request Info3 year and older
All sexes
Observational
Dermatology Hospital of Bamako, Bamako, Mali
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Study Group):
Inclusion criteria
(Healthy Volunteers):
Exclusion criteria
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.
Time frame: Within 28 days after the screening visit.
RNAseq
Time frame: Within 28 days after the screening visit.
Metagenomic sequencing
Time frame: Within 28 days after the screening visit.
Metagenomic sequencing
Time frame: Within 28 days after the screening visit.
Patient survey to establish risk. Higher exposure, linked to higher atopy risk.
Time frame: Within 28 days after the screening visit.
Time frame: Within 28 days after the screening visit.
Contact information is provided by the study sponsor or research team.
Cisse Lamissa, MD
CONTACT
Khadida Ouattara, MD, MSc
CONTACT
National Institute of Allergy and Infectious Diseases (NIAID)
Nih
Analyzing the Microbiome and Environmental Exposures of Patients Suffering From Atopic Diseases in Mali
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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