NCT07602751尚未招募1 期
Fecal Microbiota Transplantation for the Treatment of Steroid-refractory Graft-versus-host Disease.
Bambino Gesù Hospital and Research Institute3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年5月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 3
研究概览
简要总结
This is a pilot, prospective, non-profit, multicenter, uncontrolled, open-label study to evaluate the safety and feasibility of FMT in patients aged between 3 months and 25 years suffering from acute intestinal GVHD resistant to conventional steroid therapy.
Eligible patients will receive 1-3 FMT via naso-jejunal tube or endoscopy.
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
- 3 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hematological disease, malignant or non-malignant;
- •Patients undergoing allogeneic stem cell transplantation from a familial or unrelated donor;
- •Presence of acute GVHD with intestinal involvement (grade II-IV), steroid-resistant (i.e., with progression after 3 days of high-dose steroid therapy (methylprednisolone > 2 mg/kg), no response after 7 days, progression during steroid tapering, or failure to achieve remission on day 28 from the start of steroid therapy), for those who have no indication for other second- or third-line therapies;
- •Signed informed consent.
排除标准
- •Presence of concurrent bacterial infections requiring systemic antibiotic therapy;
- •Positivity for anti-HIV or anti-HCV antibodies, or for HbsAg with HBV-DNA positive by PCR;
- •Presence of severe mucositis;
- •History of chronic inflammatory bowel disease.
研究者
研究点 (3)
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