Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Urinary protein
研究概览
简要总结
IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Previous studies suggested that the disorder of intestinal flora may play an important role in the pathogenesis and prognosis of IgAN. Fecal microbiota transplantation (FMT) have been proved to be effective on rebuilding the intestinal microecological balance. However, there is no evidence for the safety and efficacy of FMT in IgAN. Therefore, investigators perform a prospective cohort study to evaluate the safety and efficacy of FMT in IgAN patients who did not response to the conventional treatment and did not want to aggravate immunosuppressive treatments or IgAN patients who did not response to immunosuppressive treatments.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, age: 18-65 years old.
- •Pathological diagnosis with IgAN, eGFR：20-120 mL/min/1.73 m
- •The 24-hour urinary protein was still greater than 1g after 3-6 months of treatment of ACEI/ARB
- •Recurrence of IgAN after glucocorticoid and (or)immunosuppressant decrement and the 24-hour urinary protein was greater than 1g.
- •Not suitable for the administration of glucocorticoid and (or) immunosuppressive agents because of side effects.
- •Women of child-bearing age with negative urine pregnancy test have no pregnancy plan for the next 18 months and take effective contraceptive measures.
- •Agree to participate in this clinical trial
排除标准
- •Malignant tumors and other diseases with expected survival time <3 months.
- •Severe cardiovascular and cerebrovascular diseases and pulmonary dysfunction.
- •Other immune system diseases.
- •Inflammatory bowel disease（IBD）
- •Clostridium difficile infection
- •Gastrointestinal tumor
- •Active gastrointestinal bleeding
- •Acute and chronic gastroenteritis
- •Have received or are receiving FMT treatment.
- •Psychosis AND dysgnosia
- •Contraindication of colonoscopy and enema
- •Alcohol/drug abuse
- •Other conditions that the researchers thought were not appropriate for the group.
研究组 & 干预措施
FMT treatment
FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.
干预措施: Fecal microbiota transplantation (Biological)
结局指标
主要结局
Change of Urinary protein
时间窗: one time per week up to 8 weeks
24 hours urinary protein quantity
次要结局
- Change of Serum creatinine(one time per week up to 8 weeks)
- Change of eGFR(one time per week up to 8 weeks)
- Change of Hematuria(one time per week up to 8 weeks)
- Change of Blood pressure(one time per week up to 8 weeks)
- Change of Serum IgA1(one time per week up to 8 weeks)
- Change of Fecal microbiota(one time per week up to 8 weeks)
- Adverse events associated with FMT(one time per week up to 8 weeks)
研究者
Shiren sun
MD, Professor
Air Force Military Medical University, China