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临床试验/NCT04290429
NCT04290429已完成早期 1 期

Analysis of the Effect of Teduglutide Treatment on Intestinal Malabsorption and Paneth Cell Numbers in Patients With Steroid-refractory Gastrointestinal Graft Versus Host Disease (SR-GI-GVHD).

University of Freiburg1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年12月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
6
试验地点
1
主要终点
Paneth cell numbers

研究概览

简要总结

In this study the investigators evaluate the outcomes of six steroid-refractory GVHD patients with gastrointestinal signs of GVHD that were treated with teduglutide.

详细描述

Preliminary studies have showed that Glucagon-like peptide 2 (GLP-2) has regenerative and protective effects on the gastrointestinal tract after bowel injury. It induces positive effects in the GI tract like nutrient uptake, mucosal growth, protection from inflammation, etc. One of the target organs from GVHD is the GI tract, and since patients suffering from GI-GVHD experience intestinal disorders like loss of mucosal epithelial integrity, diarrhea accompanied by strong abdominal pain that can lead to food inanition, the investigators therefore aimed to examine the outcome of patients suffering from SR-GI-GVHD that are treated with the GLP-2 analogue, Teduglutide. The investigators will determine the outcome of each patient by monitoring the gastrointestinal signs like diarrhea frequency, intestinal absorption measured by serum-albumin concentrations and GI histology, specifically the number of Paneth cells before and during teduglutide treatment.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with signs of acute SR-GI-GVHD
  • Age ≥ 18 years
  • Peripheral blood and stool samples available before and during treatment
  • Written informed consent
  • Ability to understand the nature of the study and the study related procedures and to comply with them

排除标准

  • Age ≤ 18 years
  • Lack of informed consent

研究组 & 干预措施

SR-GI-GVHD

Experimental

Analysis of patient's stool frequency, albumin serum levels and quantification of Paneth cell numbers in GI biopsies before and during teduglutide treatment.

干预措施: Teduglutide (Drug)

结局指标

主要结局

Paneth cell numbers

时间窗: 2 years

Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.

次要结局

  • Stool frequency(2 years)
  • Intestinal absorption(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Zeiser

Director of the Division of Tumor Immunology

University of Freiburg

研究点 (1)

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