Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Percent donor engraftment
研究概览
简要总结
HS is relatively common in the United States with a prevalence of 0.1-1.0%. 1 HS has a dramatic impact on quality of life, significantly more so than other chronic skin diseases, such as psoriasis or atopic dermatitis (AD). HS also has a large economic impact, due to frequent emergency department and inpatient care utilization, and re-hospitalization rates similar to congestive heart failure. Unfortunately, few treatment options are effective. There are currently three FDA-approved treatments for HS, including adalimumab, secukinumab, and bimekizumab, each with only 40- 60% respond to treatment and over 50% lose response within one year . The overarching goal of this pilot study is to investigate the central hypothesis that oral microbiota transplant therapy(MTT) alters the gut microbiome in patients with Hidradenitis Suppurativa (HS), influencing cutaneous microbiota via systemically absorbed gut-derived metabolites.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent
- •English speaking
- •Age >= 18years of age
- •Diagnosis of hidradenitis suppurativa by a dermatologist
- •Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g. absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g. oral contraception, transdermal patch, barrier, intrauterine device). Periodic abstinence and early withdraw are not acceptable methods
- •Able to comply to study measures in the opinion of the investigator.
- •Stable doses of all medications for 30 days prior to baseline
排除标准
- •Non-English speaking
- •Refusal or inability to provide informed consent
- •Planning on moving within 6 months from start of study
- •Allergy to neomycin or vancomycin
- •Anaphylactic food allergies
- •Pregnancy, breastfeeding or planning pregnancy during study period (negative pregnancy test needed for persons of childbearing potential)
- •Use of any topical or oral antibiotics within 30 days of randomization
- •Use of any oral antibiotics within 90 days of randomization
- •History of inflammatory bowel disease
- •Extensive bowel resection (e.g., subtotal colectomy, substantial removal of small bowel)
- •No major bowel surgery within 4 weeks prior to baseline or planned major surgery during the study period
- •No active skin disease other than HS that could interfere with assessments
研究组 & 干预措施
Placebo group
patients with HS randomized to receive placebo treatment
干预措施: Placebo drug (Drug)
MMT group
patients with HS randomized to receive MTT
干预措施: Fecal Microbiota - lyophilized (Drug)
结局指标
主要结局
Percent donor engraftment
时间窗: Baseline, 6 weeks, 12 weeks
Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking
次要结局
- Change in Dermatology Life Quality Index (DLQI)(12 weeks)
- Change in hidradenitis suppurativa patient global assessment(12 weeks)
- Stool small chain fatty acids(12 weeks)
- Physician-reported clinical response 1(12 weeks)
- Change in skin pain numerical rating scale (NRS)(12 weeks)
- Change in the Hidradenitis Suppurativa Activity and Severity Index(12 weeks)
- Stool toxonomic relative abundances and diversity indices(6 weeks, 12 weeks)
- Serum small chain fatty acids(12 weeks)
- Stool small molecule metabolites(6 weeks, 12 weeks)
- Physician-reported clinical response 2(12 weeks)
- Change in IHS4(12 weeks)
- Change in total draining tunnel count(12 weeks)
- Skin toxonomic relative abundances and diversity indices(6 weeks, 12 weeks)
- Change in Hidradenitis Suppurativa quality of life (HiSQOL)(12 weeks)