Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Assessment of the change in the severity of Atopic Dermatitis after treatment with Fecal Microbial Transplantation
研究概览
简要总结
Prospective single-blinded placebo-controlled cross-over study, among adult patients suffering from moderate-to-severe atopic dermatitis (AD), insufficiently responsive to topical and systemic treatment. All patients receive 2 placebo transplantations each 2 weeks apart followed by 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. Patients were allowed to continue with their baseline medical topical treatment, including moisturizers and glucocorticoids, during the study period, but no new therapy was commenced. The severity of AD and the fecal microbiome profile was evaluated by the Scoring Atopic Dermatitis Score (SCORAD score), and the weekly use of topical corticosteroids, at the beginning of the study, before every FMT, and 1-6 months after the last FMT.
详细描述
Prospective single-blinded placebo-controlled cross-over study, among adult patients suffering from moderate-to-severe atopic dermatitis (AD), insufficiently responsive to topical and systemic treatment. All patients receive 2 placebo transplantations each 2 weeks apart followed by 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. Patients were allowed to continue with their baseline medical topical treatment, including moisturizers and glucocorticoids, during the study period, but no new therapy was commenced. The severity of AD and the fecal microbiome profile were evaluated by the Scoring Atopic Dermatitis Score (SCORAD score), and the weekly use of topical corticosteroids, at the beginning of the study, before every FMT, and 1-6 months after the last FMT.
During the study period, patients were allowed to use only topical therapy including emollients and glucocorticoids or calcineurin inhibitors.
FMT preparation and delivery:
Volunteer donors were healthy, non-pregnant adults aged 18 to 50 years, with a normal body mass index. Volunteer donors were excluded for any significant medical history or for any use of antibiotics in the preceding 3 months. Candidates were eligible according to the Israeli Ministry of Health guidelines which include a physical examination and laboratory screening tests including fecal enteric pathogens, serum antibodies to hepatitis A, B, and C; human immunodeficiency virus; HTLV, and Treponema pallidum as well as celiac, CBC (and additional tests that comply with the guidelines of the Israeli Ministry of Health). Stool was delivered within minutes post defecation in a clean closed plastic container and was processed at the Tel Aviv Medical Center stool bank facility to prepare capsulized FMT. Briefly, fecal material was diluted with normal saline (600ml/100g of fecal material), filtered and concentrated the preparation in a centrifuge. The pellet was suspended in sterile saline and glycerol (20%) that was added as a bacterial cryoprotectant. This material was then pipetted into acid-resistant capsules, which was closed and then secondarily sealed with additional set of capsules. Capsules were stored frozen at -80°C. Placebo capsules had identical visually and contained diluted glycerol only.
Capsulized FMT procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are ≥18 years of age
- •Moderate-to-severe atopic dermatitis, as defined by a Scoring Atopic Dermatitis Score (SCORAD) score ≥25
- •Disease duration minimum of 3 years that was inadequately controlled by topical and systemic therapy
排除标准
- •Age under 18 years
- •Pregnancy
- •Another concomitant active dermatologic disease.
- •Receiving systemic therapy including phototherapy within 4 weeks before the beginning of the study.
- •Receiving any antibiotic or probiotic treatment within 4 weeks before the beginning of the study or during the study
结局指标
主要结局
Assessment of the change in the severity of Atopic Dermatitis after treatment with Fecal Microbial Transplantation
时间窗: 2 weeks after each FMT, and 8 weeks or more after the last FMT
Overall mean change from baseline of the Scoring atopic dermatitis score (SCORAD), described and validated by the European Task Force on Atopic Dermatitis, used for the assessment of the severity of Atopic Dermatitis. The minimal SCORAD score, describing a situation without any signs of atopic dermatitis is 0, the disease is not visible, while the maximal score, describing the most severe presentation of atopic dermatitis, is 103.
次要结局
- Assessment of the degree of bacterial strain transmission from donor to patient after treatment with Fecal Microbial Transplantation(2 weeks after each FMT, and 8 weeks or more after the last FMT)
- Assessment of the correlation between bacterial stains transmission from donor to patient to the SCORAD score change after treatment with Fecal Microbial Transplantation(2 weeks after each FMT, and 8 weeks or more after the last FMT)