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临床试验/NCT02897661
NCT02897661Unknown不适用

Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
changes in hemoglobin

研究概览

简要总结

Patients with Crohns' disease (CD) are always complicated with malnutrition. Exclusive enteral nutrition (EEN) is an effective treatment to improve nutritional status and induce remission in patients with CD however a reduction in microbiota diversity was the most frequently reported effect of EEN. There was a raised critical question that whether EEN combining microbiota transplantation can bring much more benefits to those CD patients with malnutrition.

Fecal microbiota transplantation (FMT) is an effective way of remodeling microbiota. The improved methodology of FMT in our group since 2014 was different from the traditional manual FMT and was recently coined as washed microbiota transplantation (WMT), which is dependent on the automatic facilities and washing process in a laboratory room with biosafety level 3.

Importantly, the worse nutritional status might decrease the efficacy of FMT. Therefore, there was a raised critical question that when is the proper time to combine WMT for those CD patients requiring EEN. This trial aimed to explore the timing of WMT in CD patients with malnutrition and assess the efficacy and safety of the strategy using WMT combined with EEN in CD patients.

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
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

入选标准

  • patients aged 18 to 65 years with active CD, as defined by Harvey-Bradshaw Index (HBI) score >4;
  • patients accompanied with malnutrition as assessed by Nutritional Risk Screening 2002 (NRS2002) score ≥ 3 or Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4;
  • patients with high compliance.

排除标准

  • accompanying with contraindications of enteral nutrition (EN) such as ileus, active gastrointestinal bleeding and shock;
  • severe comorbidities (e.g., Clostridium difficile infection, diabetes, cancer, cardiopulmonary failure and severe liver and kidney diseases;
  • parenteral infection such as urinary infection, pneumonia, etc;
  • steroids or biologicals use within 6 week;
  • intestinal fibrotic stenosis;
  • patients who are pregnant or going to be pregnant;
  • patients with mental disorders.

结局指标

主要结局

changes in hemoglobin

时间窗: Day 8 and day 15

changes in albumin and prealbumin in g/L

时间窗: Day 8 and day 15

changes in lymphocyte count in 10^9/L

时间窗: Day 8 and day 15

次要结局

  • rate of clinical remission(day 15)

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faming Zhang

Associate professor, Gastroenterology

The Second Hospital of Nanjing Medical University

研究点 (1)

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