NCT03926286已完成1 期
Fecal Microbial Transplant for Sjogrens Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with reported adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •Inability to provide informed consent and/or unable or unwilling to comply with protocol requirements.
- •Antibiotics for at least 2 weeks prior to FMT.
- •Active infection for >15 days: bacteremia, urinary tract infection, pneumonia or abdominal collection.
- •Known or suspected toxic megacolon and/or known small bowel ileus.
- •Previous FMT
- •Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
- •History of total colectomy or bariatric surgery.
- •Antibiotics for the treatment of an active infection or anticipated antibiotic use during trial duration.
- •Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.
- •Expected life expectancy < 6 months
- •Patients with a history of severe anaphylactic or anaphylactoid food allergy.
- •Solid organ transplant patients ≤ 90 days post-transplant or on active treatment for rejection.
- •Neutropenia (<500 neutrophils/mL) or other severe immunosuppression. Patients on monoclonal antibodies to B and T cells, anti-tumor necrosis factor, glucocorticoids, antimetabolites, calcineurin inhibitors may be enrolled after consultation with their medical doctor.
- •Renal failure (GFR <30 or dialysis)
- •Human immunodeficiency virus+ controlled or not well controlled on antiretroviral therapy
- •Regular probiotic supplement use within prior 2 weeks to enrollment
- •Pregnancy or inability/unwillingness to use contraceptives.
- •A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
- •Exclusion on the discretion of the PI.
研究组 & 干预措施
FMT for Sjogrens
Experimental
FMT- active ingredient coming from participant's screening stool
干预措施: FMP-30 (Drug)
结局指标
主要结局
Number of participants with reported adverse events (AEs) and serious adverse events (SAEs)
时间窗: 7 months
As an evaluation of the safety of FMT, the number of participants with reported AEs and SAEs will be collected. All occurrences of AEs and SAEs, regardless of relatedness to FMT, will be reported and assessed by the clinician using the NIH CTCAE.
Number of participants with stable microbiome engraftment
时间窗: month 3
Engraftment will be analyzed via the Jensen-Shannon divergence (JSD). The engraftment scores will be the ratio between the donors and recipients at the bacterial genus level. Participants who successfully engraft will more closely resemble the donor microbial profile on JSD analysis.
次要结局
- Change in ocular and systemic symptoms as measured by the quality of life SF-12 Questionnaire(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Change in self-reported ocular pain as assessed by the Short-form McGill Pain Questionnaire(SFM-PQ)(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Anxiety as assessed by the Symptom Checklist 90 for Anxiety (SCL-90 Anxiety)(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Change in self-reported ocular pain as assessed by the Neuropathic Pain Symptom Inventory (NPSI)(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Depression as assessed by the Symptom Checklist 90 for Depression (SCL-90 Depression)(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Change in dry eye symptoms(baseline, 1 week, 1 month, 3 months)
- Change in diversity of bacterial communities(Pre FMT, 3 months post FMT)
- Change in system immune profiles as measured by T cell populations(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Change in self-reported ocular pain as assessed by the Numerical Rating Scale(NRS)(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
- Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(Pre-FMT, 1 Week, 1 Month, 3 months post FMT)
研究者
Anat Galor
Associate Professor
University of Miami
研究点 (1)
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