The Role of Gut and Skin Microbiota in Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in hair growth- Severity of Alopecia Tool
研究概览
简要总结
The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) works to treat alopecia areata in adults. It will also learn about the safety of FMT. The main questions it aims to answer are:
- Can FMT cause hair regrowth?
- Can FMT modulate immune response? Researchers will compare FMT to a placebo (a look-alike substance that contains no drug) to see if FMT works to treat alopecia areata.
Participants will:
- Take FMT or a placebo for three consecutive days
- Follow-up evaluations will be performed at weeks 12, 24, and 48, with repeat clinical scoring, photodocumentation, microbiome analyses, laboratory testing, and quality-of-life assessment.
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
- None
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
- •Adults aged 18-65 diagnosed with Alopecia Areata (patchy or extensive) up to 10 years
- •Willingness to adhere to study protocols, including FMT administration via capsules or colonoscopy.
- •Ability to sign informed consent.
- •SALT score≥ 20
排除标准
- •History of gastrointestinal disorders (e.g., IBD, celiac disease).
- •Recent use of antibiotics, probiotics, or prebiotics (within 2 months).
- •Pregnant or breastfeeding women of childbearing potential who are unwilling or unable to use an acceptable method of birth control.
- •Individuals with immunocompromised or immunosuppressed states (e.g., HIV, cancer).
- •Prior FMT treatment for any condition.
- •Therapy with new antidepressants or had a change in antidepressant dose within previous 3 months
- •Serious medical comorbidities(including neurological or phychiatric comorbidities)
- •Elevated C-reactive protein concentration, abnormal baseline laboratory tests
- •Severe(anaphylactic) food allergy
- •Concomitant treatments for AA: topical KS 1 week prior to randomization, topical JAK inhibitor, diphenylcyclopropenone, or other topical immunotherapies within 4 weeks prior to randomization;systemic corticosterids, immunosuppressant, intra-lesional or intra-articular corticosteroid injections, or oral JAK inhibitor within 8 weeks prior to randomization;monoclonal antibody <5 half-lives prior to randomization; probenecid at the time of randomization. Bimatoprost ophtalmic solution was allowed if on stable dose for 8 weeks.
结局指标
主要结局
Changes in hair growth- Severity of Alopecia Tool
时间窗: From enrollment to the end of treatment at 48 weeks
The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in SALT (Severity of Alopecia Tool) score as a standardized measurement used to quantify scalp hair loss in patients with alopecia areata. The scale ranges from 0 (no hair loss) to 100 (complete scalp hair loss). A clinically meaningful reduction in SALT score (≥50% improvement from baseline) will be considered a strong indicator of therapeutic efficacy.
Changes in hair growth- Alopecia Areata Investigator Global Assessment
时间窗: From enrollment to the end of treatment at 48 weeks
The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in Alopecia Areata Investigator Global Assessment (AA-IGA) to measure five clinically meaningful gradations of alopecia areata scalp-hair loss that reflects patients' and clinicians' perspectives and expectations of treatment success in alopecia areata treatment studies. The AA-IGA score is based on the patient's SALT score. The scale is numbered from 0, which corresponds to 0% of hair loss (ie, SALT 0), indicating no hair loss, to 4, which corresponds to 95-100% of hair loss (ie, SALT 95-100), indicating very severe hair loss.
Changes in hair growth- The Alopecia Areata Scale
时间窗: From enrollment to the end of treatment at 48 weeks
The primary success will be a statistically significant difference in hair regrowth between the Fecal Microbiota transplantation (FMT) group and placebo group at weeks 24 and 48, assessed as a binary endpoint (regrowth yes/no) and supported by changes in The Alopecia Areata Scale (AASc) in wich primary criterion is Severity of scalp hair loss: mild 20% or less, moderate 21-49%, severe 50-100% scalp hair loss. Secondary criteria: is any is present, increase severity rating by one level: noticeable involvement of eyebrows or eyelashes; inadequate response after at least 6 months of treatment; negative impact on psychosocial functioning resulting from AA; diffuse (multifocal) positive hait pull test consistent with pidly progressive alopecia areata.
Fecal microbiota transplantation modulation of the gut and skin microbiota
时间窗: From enrollment to the end of treatment at 48 weeks
The primary objective of this proposal is to test the hypothesis that fecal microbiota transplantation (FMT) induces beneficial modulation of the gut and skin microbiota, leading to immunoregulatory effects in patients with alopecia areata (AA). Characterize baseline skin, and colonic mucosal microbiota composition in patients with AA using 16S rRNA sequencing of skin and colon musosa biopsy specimens and assess changes following FMT.
Change in T cell subsets from Baseline to 48 weeks
时间窗: From enrollment to the end of treatment at 48 weeks
Before and after Fecal microbiota transplantation patient will be taken 60-80 ml of peripheral blood for: * CBC, CRP * Flow cytometry analyses: Tumor necrosis factor alfa (TNFɑ), IL-10, IL-18, IFN-γ, IL-15, IL-2 and trichohyalin; CD4+ Th1 lymphocytes, CD8+ cytotoxic T cells, IFN-γ-producing lymphocytes, CXCR3+ T cells, NK cells, ILC1-like innate lymphoid cells, activated T cells expressing CD69 and HLA-DR, and regulatory T cells (CD4+CD25+FOXP3+)
次要结局
未报告次要终点
研究者
Tea Rosovic
Dermatovenerology specialist
Polyclinic GrandMed