Randomized, Double-blind and Placebo-controlled Clinical Study to Evaluate the Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioithas SL
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes from baseline in signs of AA activity visualized by capillary trichoscopy at 16 and 24 weeks
研究概览
简要总结
This study is part of a broader project that proposes the characterization of what we call the "Entire-Systemic Axis". It aims to study whether the bacteria present in the human skin microbiota and in the human intestinal microbiota can play a role in the pathophysiology of Alopecia Areata (AA), a fact that has not been studied to date. Based on the supposed relationship between the human microbiota and AA, we have formulated the hypothesis that the dietary supplementation of specific probiotic strains, with functional capacities on mucocutaneous tissue and its adnexa, could benefit patients with AA, acting on the patients' microbiome profile.
详细描述
This clinical study was designed to be a randomized, double-blind, with parallel-groups, and placebo-controlled with a duration of 24 weeks duration.
The 24 weeks of intervention were structured in 6 face-to-face visits in consultation: visit 1 or initial (week 0), visit 2 (week 4), visit 3 (week 8), visit 4 (week 12), visit 5 (week 16) and visit 6 or end of study (week 24).
Visit 1 or initial (Week 0)
To recruit patients, all those voluntaries who attended the participating centre showing interest in the study with AA diagnosis meeting the criteria indicated in the study protocol were thoroughly informed of the study as well as of the implications of their participation.
Once the informed consent was signed a physician trained for the study conducted the initial interview The researcher proceeded to assign the patient a participant number in the study. According to a previously prepared randomization list, the patient was assigned the treatment received during the study by contacting the randomization centre Likewise, in this initial visit, the clinical history and capillary measurements were made: trichoscopy, plaques counting and photographs. In addition, the patient underwent a blood draw, and a skin sample from the area of plaques as well as sample of faeces was collected.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AA diagnosis by clinical criteria.
- •Show at least 2 signs of AA activity, visualized by trichoscopy
- •Signature of informed consent by the patient, in accordance with the legislation on clinical trials.
排除标准
- •Allergies or contraindication to take any of the components of the product under study.
- •Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
- •Consumption of probiotics in the previous 2 months. - Participation in clinical studies in the previous 2 months.
- •Pregnancy and/or lactation.
结局指标
主要结局
Changes from baseline in signs of AA activity visualized by capillary trichoscopy at 16 and 24 weeks
时间窗: 24 weeks
The signs of AA activity assessed in trichoscopy were: * Black dots (cadaveric hairs). Pigmented broken or fractured hairs at the level of the scalp * Broken or exclamation mark hairs (peladic hairs). Fractured hairs with the distal end frayed and thicker. * Broken hairs * Tapered hairs (coudability hairs). Hairs of normal length, but with a narrower proximal shaft (indicating activity at the base of the hair). * Pseudomonilethrix
Changes from baseline in signs of AA inactivity visualized by capillary trichoscopy at 16 and 24 weeks
时间窗: 24 weeks
The signs of AA inactivity assessed in trichoscopy were: * Yellow dots * Fluffy hairs * Empty follicular orifices
Changes from baseline in signs of capillary repopulation visualized by capillary trichoscopy at 16 and 24 weeks
时间窗: 24 weeks
The signs of capillary repopulation assessed in trichoscopy were: * Straight hairs in regrowth * Pigtail hairs * Fluffy hairs
次要结局
- Changes from baseline in haemoglobin values at 24 weeks(24 weeks)
- Changes from baseline in AA plaques number at 16 and 24 weeks(24 weeks)
- Changes from baseline in AA category/type at 16 and 24 weeks(24 weeks)
- Changes from baseline in SALT scale at 16 and 24 weeks(24 weeks)
- Changes from baseline in Interleukin-10 (IL-10) values at 24 weeks(24 weeks)
- Changes from baseline in leukocytes values at 24 weeks(24 weeks)
- Changes from baseline in platelets values at 24 weeks(24 weeks)
- Changes from baseline in urea values at 24 weeks(24 weeks)
- Changes from baseline in creatinine values at 24 weeks(24 weeks)
- Changes from baseline in Thyroid-stimulating Hormone (TSH) values at 24 weeks(24 weeks)
- Changes from baseline in C-reactive protein values at 24 weeks(24 weeks)
- Changes from baseline in Aspartate Aminotransferase (AST) values at 24 weeks(24 weeks)
- Changes from baseline in Alanine Aminotransferase (ALT) values at 24 weeks(24 weeks)
- Changes from baseline in Tumor Necrosis Factor (TNF) values at 24 weeks(24 weeks)
- Changes from baseline in Immunoglobulin E (IgE) values at 24 weeks(24 weeks)
- Changes from baseline in Dermatology Life Quality Index (DLQI) scale at 24 weeks(24 weeks)
- Changes from baseline in alpha diversity, beta diversity and composition of the skin and gut microbiota at 24 weeks(24 weeks)
- Adherence to treatment at 4,8,12,16 and 24 weeks(24 weeks)