Efficacy of Probiotics as an Adjunct to Standard Therapy in Androgenetic Alopecia(HAIR loss) : RCT (PRO- HAIR study )
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in hair density measured objectively via standardized trichoscopic imaging and quantified using validated software-based analysis.
研究概览
简要总结
Androgenetic alopecia, also known as male or female pattern hair loss, is the most common type of hair loss, affecting up to 80% of men and 50% of women by the age of 70. It is caused by a combination of genetics and hormones, especially a form of testosterone called dihydrotestosterone. Current treatments such as topical minoxidil, oral finasteride, platelet-rich plasma injections, and growth factor therapies mainly work at the scalp level but may not address deeper body-wide issues.
Recent research has shown that gut health may play a role in hair growth. An imbalance in gut bacteria—called dysbiosis—has been linked to several skin and hair problems.Probiotics, which are beneficial bacteria, may help improve hair condition by restoring gut balance, reducing inflammation, and improving nutrient absorption.
This study will explore whether taking probiotics alongside standard hair loss treatments can improve hair growth and patient satisfaction. It will also examine changes in gut bacteria before and after treatment, to see if any patterns are linked with better outcomes.
This study may significantly impact the management paradigm of androgenetic alopecia by validating the clinical utility of probiotics as a systemic adjunct.
By profiling gut microbiota and correlating it with hair parameters and treatment responses, the study also contributes to the growing field of personalized medicine. Identifying microbial biomarkers for prognosis or therapeutic success could open doors to precision-targeted interventions in AGA and related conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18 to 50 years with clinically diagnosed AGA (Hamilton–Norwood scale for men, Ludwig scale for women).
- •No antibiotic or probiotic use in the past month.
- •Willingness to provide stool samples and adhere to study protocols.
排除标准
- •Presence of other forms of alopecia (e.g., alopecia areata).
- •Gastrointestinal disorders or systemic inflammatory conditions.
- •Immunocompromised status or use of immunosuppressive medications.
结局指标
主要结局
Change in hair density measured objectively via standardized trichoscopic imaging and quantified using validated software-based analysis.
时间窗: 0,4 weeks,8 weeks,12 weeks and 16 weeks
次要结局
- Patient-reported outcomes on hair satisfaction and quality of life using Validated Questionnaire(Assessment of gut microbiota composition through 16S rRNA sequencing of stool samples before the start of treatment and at 16 weeks after initiation of probiotic treatment. Bacterial 16S rRNA gene sequences (V3–V4 regions) will be amplified from the whole genome using the primers, 341F and 805R and amplicon libraries will be sequenced on an Illumina NovaSeq platform.)
研究者
Dr Palreddy Akshara
AIIMS, Delhi
