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Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis


Phase 2
2 Years
40 Years
Open (Enrolling)
Both
Dermatitis, Atopic, Human Volunteers, Eczema, Atopic Dermatitis

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Trial Information

Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis


Background:

- 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.

Objectives:

Primary:

-To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and
pediatric patients with AD (Cohort 3) after antimicrobial treatments.

Secondary:

- 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.

Eligibility:

- 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

bacterial infection

-(Cohort 3) Objective SCORAD (SCORing Atopic Dermatitis) score of greater than or equal to
15 indicating moderate-to-severe disease

Design:

- A prospective, interventional, longitudinal study examining changes in microbiome
resulting from randomized, placebo-controlled, investigator-blinded antimicrobial
treatments.

- 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
baths

- All subjects will undergo longitudinal microbiome sampling.

- AD patients will undergo clinical assessment to determine responses of skin infections
to treatment

Inclusion Criteria


- INCLUSION CRITERIA:

Cohorts 1 and 2: Healthy Volunteers

Males and females aged 18-40 years.

- Subjects must participate fully and be willing to comply with the procedures of the
protocol

- Subjects must be co-enrolled in NIH protocol 08-HG-0059

- Ability of subject to understand and provide phone and or written informed consent.

Cohort 3: Atopic Dermatitis Patients

- Subjects must be aged 2-25 years.

- Subjects must be co-enrolled in NIH protocol 08-HG-0059

- Subjects must have a diagnosis of atopic dermatitis

- Subjects must have a primary care provider.

- Prior to initiation of treatment, subjects must have signs of bacterial skin
infections (skin weeping, crusting, and or pustules).

- All subjects and/or their Legally Authorized Representative (LAR) must have the
ability and agree to participate fully and comply with the procedures of the protocol
and provide informed consent. Pediatric patients will be included in age appropriate
discussions and age appropriate assent will be obtained in accordance with NIH
guidelines.

EXCLUSION CRITERIA:

Cohorts 1 and 2: Healthy Volunteers

- Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling

- Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks
of initiation of treatment.

- History of eczema and asthma.

- Known allergic reaction to certain antibiotics.

- Pregnant or lactating.

- Subjects with a primary or acquired immunodeficiency, including HIV seropositivity.

- Any chronic past or present medical illness, including chronic skin diseases like
psoriasis.

- Subjects receiving or planning to receive an IND agent, ultraviolet light therapy,
monoclonal antibodies, or systemic immunosuppressants.

Cohort 3: Atopic Dermatitis Patients

- Does not meet inclusion criteria.

- Known allergic reaction to certain antibiotics.

- Use of topical or oral CAM agents within 4 weeks of initiation of treatment.

- Subjects with known primary or acquired immunodeficiency.

- Subjects with unstable or uncontrolled medical conditions that could require
hospitalization during the initial month of the study or who have been hospitalized
for treatment of these conditions in the one month prior to baseline sampling.

- Subjects receiving or planning to receive an IND agent, ultraviolet light therapy,
monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives
(whichever is the longer time period) of initiating treatment on this protocol.

- Subjects who are currently receiving or have received chemotherapy or radiation for
treatment of malignancies within the previous 6 months.

- Pregnancy or lactating.

- Smokers and subjects who use smokeless tobacco products.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 weeks

Safety Issue:

No

Principal Investigator

Heidi H Kong, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

120159

NCT ID:

NCT01631617

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Dermatitis, Atopic
  • Human Volunteers
  • Eczema
  • Atopic Dermatitis
  • Investigator-Blinded
  • Skin Biopsy
  • Randomized
  • Antibiotics
  • Topical
  • Dermatitis
  • Dermatitis, Atopic
  • Eczema

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892