Fecal Transplant for Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Alopecia Areata Progression Index, AAPI
研究概览
简要总结
the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA.
详细描述
Alopecia areata (AA) is a common autoimmune disease that triggers non scarring hair loss in different severities. Usually the hair loss will be contained to the scalp and / or beard, but in some cases, there will be total hair loss from the entire scalp (alopecia totalis), or complete loss of all body, facial and scalp hair (alopecia universalis).
AA is an autoimmune disease that produces an inflammation surrounding the hair follicles, this leads to temporary hair loss. In cases the disease become chronic, the immune system attack may lead to a permanent hair loss. This common hair disease has a significant impact on the patient's quality of life, it can cause impairment on the patient's confidence, self-esteem, lead to depression and more.
Lately two patients with AA and clostridium difficile infection were treated with fecal transplantation for their infection (Rebello et al. 2017). After the transplant a significant improvement was notice in hair growth. These 2 cases raised the option that a fecal transplant may have an additional effect on the autoimmune reaction against the hair follicle in AA.
the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AA patients with:
- •Acute disease that appeared in the last 3 months.
- •Recurrence of AA in the last 3 months, in a patient who had remission for at least one year.
- •At least one patch of hair loss on the scalp and / or the beard, or with a widespread disease such as total loss of the hair over the entire scalp (alopecia totalis).
- •In case of a single alopetic patch, the patch must be equal or bigger than 2 cm in diameter.
- •All patients will be diagnosed by two separate dermatologist, or one dermatologist with the support of classical finding on skin biopsy.
排除标准
- •Patients who were treated with systemic corticosteroids / corticosteroids injection one year prior the study.
- •Patients who were treated with topical corticosteroids two weeks prior the study.
- •Patients who were treated with immunosuppressing medications or biological treatments one year prior the study.
- •Patients who were treated with systemic antibiotics of any kind 3 months prior the study.
- •Patient who were treated with topical antibiotics one months prior the study.
- •Patients who were treated with probiotics one months prior the study.
- •Patients with alopecia universalis (total loss of all body, scalp and facial hair).
- •Patients with bowel disease or an active infection including clostridium difficile.
- •Pregnant and breastfeeding women.
- •Childrenbelow the age of
- •Malignant disease in the past 5 years.
- •Patient with any infectious disease that require antibiotics during the study period.
- •In any case a patient would like to withdraw from the study, for any reason, all samples will be destroyed immediately, and the patient will stop his participant in the study.
结局指标
主要结局
Alopecia Areata Progression Index, AAPI
时间窗: up to1 year after fecal transplantation
formula for the total AAPI score (possible score range: 0-600). The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T) using the Olsen/Canfield tool. The percent alopecic area (%AA) and score of hair loss activity (SL) is determined in each quadrant. The %AA is defined as the percentage of alopecic area in each compartment. SL is calculated as the sum of the results of hair pull tests (2 = positive, excessive, i.e. \>20% of grasped hairs; 1 = positive, not excessive, 10-20%; 0 = negative, \<10%) and the magnification findings associated with hair loss activity such as exclamation mark hairs, broken hairs and black dots (4 = ≥50%, 2 = \<50%, 0 = 0%) in each quadrant. The total AAPI score is calculated by the following formula: \[%AA(L) × SL(L) × 0.18\] + \[%AA(R) × SL(R) × 0.18\] + \[%AA(T) × SL(T) × 0.4\] + \[%AA(B) × SL(B) × 0.24\]. (possible score range: 0-600)
Severity alopecia tool score - SALT score I
时间窗: up to1 year after fecal transplantation
The SALT score I (Olsen, 2004) is a global severity score that captures percentage hair loss. The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T). Photographs taken of the four views of the scalp. The percentage of hair loss in any one of the four views (areas) of the scalp = the percentage hair loss X percent surface area of the scalp in that area. 1. left side view = ALOPECIA% x 18% 2. right side view = ALOPECIA% x 18% 3. top of scalp = ALOPECIA% x 40% 4. back of scalp = ALOPECIA% x 24% The SUM of all equals the score. (possible score range: 0-100)
patient assessment.
时间窗: up to1 year after fecal transplantation
1. \<25% regrowth. 2. 25%\<x\<50% regrowth. 3. 50%\<x\<70%regrowth. 4. \>75% regrowth. 5. 100% regrowth.
次要结局
未报告次要终点
研究者
Eli Sprecher, MD
Liat Samuelov MD. Vice Chair, Division of Dermatology, Tel Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center