Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
- The use of antibiotics has revolutionized medicine, yet the impact of antimicrobials on
the human microbiome is incompletely understood.
- Antimicrobial treatments, including topical and systemic antibiotics, are highly
effective and are frequently used to manage disease flares of AD. Concomitant use of
dilute bleach baths reduces the clinical severity of AD in patients with clinical signs
of bacterial skin infections.
- The longitudinal impact of various antimicrobials on the human microbiome, particularly
in skin, has not been systematically investigated.
-To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and
pediatric patients with AD (Cohort 3) after antimicrobial treatments.
- To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis
of human microbes.
- To examine how different antimicrobials may alter the human microbiome.
- All subjects must be co-enrolled in NIH protocol 08-HG-0059
- (Cohorts 1 and 2) Healthy volunteers aged 18 to 40 years with no history of AD
- (Cohort 1 and 2) No prior use of systemic antibiotics in preceding 12 months
- (Cohort 3) Subjects 2-25 years with atopic dermatitis with symptoms of active
-(Cohort 3) Objective SCORAD (SCORing Atopic Dermatitis) score of greater than or equal to
15 indicating moderate-to-severe disease
- A prospective, interventional, longitudinal study examining changes in microbiome
resulting from randomized, placebo-controlled, investigator-blinded antimicrobial
- Subjects in Cohort 1 will be randomized to take one of 4 open label antibiotic regimens
- Subjects from Cohort 2 will be will be randomized to one of four possible blinded
treatment combinations of study baths and antibiotics.
- Subjects in Cohort 3 will be randomized to a cephalexin regimen with or without study
- All subjects will undergo longitudinal microbiome sampling.
- AD patients will undergo clinical assessment to determine responses of skin infections
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and pediatric patients with AD and associated active bacterial infection (Cohort 3) after treatment.
Heidi H Kong, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|