NCT01631617招募中2 期
Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年9月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Characterize microbiome alterations
研究概览
简要总结
Background:
- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin.
Objectives:
- To study the effect of eczema treatments on skin bacteria.
Eligibility:
- Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.
- Healthy volunteers between 18 and 40 years of age with no history of eczema.
Design:
- Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed.
- All participants will be assigned to one of several study groups.
- Healthy volunteers must not have taken antibiotics in the year before the start of the study.
- All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits.
- Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.
详细描述
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 atopic dermatitis (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.
- Our recent study demonstrated that antibiotic-resistant bacteria can be observed after antibiotic exposure; however, multi-year persistence has not been evaluated
OBJECTIVES:
Primary:
- To characterize microbiome alterations in healthy adult volunteers and patients with AD after antimicrobial treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Cohorts 1 [NO FURTHER ACCRUAL], 2 [INACTIVE], 4 [NO FURTHER ACCRUAL] and 5 [INACTIVE]: Healthy Volunteers
- •Males and females aged 18-50 years at time of initial protocol sampling
- •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 written informed consent
- •Access to bathing facilities (Cohort 2 [INACTIVE])
- •Ability to swallow capsules or tablets
- •Cohort 3 [INACTIVE]: Atopic Dermatitis Patients
- •Subjects must be aged 2-50 years
- •Subjects must be co-enrolled in NIH protocol 08-HG-0059
- •Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis
- •Subjects must have a primary care provider
- •Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe
- •Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules)
- •Access to bathing facilities
- •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.
- •Ability of subject to understand and provide written informed consent
- •Cohort 6: Healthy Volunteers
- •Subjects previously enrolled in Cohorts 1 [NO FURTHER ACCRUAL] and 4 [INACTIVE] who completed on-protocol antibiotic regimen
- •Subjects must participate fully and be willing to comply with the procedures of the protocol
- •Ability of subject to understand and provide written informed consent
排除标准
- •Cohorts 1 [NO FURTHER ACCRUAL] and 2 [INACTIVE]: Healthy Volunteers
- •Does not meet inclusion criteria
- •Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- •Use of systemic antibiotics in 12 months preceding baseline sampling
- •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
- •Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine
- •Family history of toxic epidermal necrolysis
- •Known allergy or sensitivity to sodium hypochlorite (NaOCl)
- •History of AD or asthma
- •Inability to comply with the requirements of the protocol
- •Pregnant or lactating
- •Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy
- •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
- •Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
- •Cohort 3 [INACTIVE]: Atopic Dermatitis Patients
- •Does not meet inclusion criteria
- •Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- •Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine
- •Family history of toxic epidermal necrolysis
- •Known allergic reaction to sodium hypochlorite (NaOCl)
- •Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling
- •Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling
- •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
- •Cohorts 4 [NO FURTHER ACCRUAL] and 5 [INACTIVE]: Healthy Volunteers
- •Does not meet inclusion criteria
- •Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause
- •Use of systemic antibiotics in 12 months preceding baseline sampling
- •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
- •(Cohort 4 [NO FURTHER ACCRUAL]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine
- •(Cohort 5 [INACTIVE]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine
- •Family history of toxic epidermal necrolysis
- •History of AD or asthma
- •Inability to comply with the requirements of the protocol
- •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
- •Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
- •Cohort 6: Healthy Volunteers
- •Does not meet inclusion criteria
- •Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling
- •Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling
- 另有 3 项未显示
研究组 & 干预措施
1C/Doxycycline 100
Active Comparator
Doxycycline 100 mg orally every 12 hours for 56 days
干预措施: Cephalexin (Drug)
1A/Cephalexin
Active Comparator
Cephalexin + Placebo bleach
干预措施: Cephalexin (Drug)
2A/Cephalexin + Dilute bleach
Active Comparator
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
干预措施: Cephalexin (Drug)
1D/Doxycycline 20
Active Comparator
Doxycycline 20 mg orally every 12 hours for 56 days
干预措施: Doxycycline (Drug)
2B/Cephalexin + Placebo bleach
Placebo Comparator
Systemic antibiotics (Cephalexin) + placebo study bath liquid
干预措施: Cephalexin (Drug)
3A/Cephalexin + Dilute bleach
Active Comparator
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
干预措施: Cephalexin (Drug)
3B/Cephalexin + Placebo bleach
Placebo Comparator
Systemic antibiotics (Cephalexin) + placebo study bath liquid
干预措施: Cephalexin (Drug)
2B/Cephalexin + Placebo bleach
Placebo Comparator
Systemic antibiotics (Cephalexin) + placebo study bath liquid
干预措施: Placebo Sodium hypochlorite (Other)
2C/Placebo capsules + Dilute bleach
Placebo Comparator
Placebo capsules + dilute bleach study bath liquid
干预措施: Placebo capsules (Other)
2A/Cephalexin + Dilute bleach
Active Comparator
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
干预措施: Sodium hypochlorite (Other)
1B/TMP/SMX
Active Comparator
TMP/SMZ DS 800 /160 orally every 12 hours for 14 days
干预措施: Trimethoprim/sulfamethoxazole (TMP/SMZ) (Drug)
1C/Doxycycline 100
Active Comparator
Doxycycline 100 mg orally every 12 hours for 56 days
干预措施: Sodium hypochlorite (Other)
2D/Placebo capsules + Placebo bleach
Placebo Comparator
Placebo capsules + placebo study bath liquid
干预措施: Placebo capsules (Other)
2D/Placebo capsules + Placebo bleach
Placebo Comparator
Placebo capsules + placebo study bath liquid
干预措施: Placebo Sodium hypochlorite (Other)
3B/Cephalexin + Placebo bleach
Placebo Comparator
Systemic antibiotics (Cephalexin) + placebo study bath liquid
干预措施: Placebo Sodium hypochlorite (Other)
2C/Placebo capsules + Dilute bleach
Placebo Comparator
Placebo capsules + dilute bleach study bath liquid
干预措施: Sodium hypochlorite (Other)
3A/Cephalexin + Dilute bleach
Active Comparator
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
干预措施: Sodium hypochlorite (Other)
结局指标
主要结局
Characterize microbiome alterations
时间窗: 2 weeks
Difference in Shannon Diversity Indices (SDI) from baseline to day 14.
次要结局
- To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.(Throughout the duration of the study)
- To examine how different antimicrobials may alter the human microbiome.(Throughout the duration of the study)
研究者
研究点 (1)
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