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临床试验/ACTRN12619000063112
ACTRN12619000063112已完成未知

Exploring the tolerability of an adjuvant dietary therapy in Ulcerative Colitis

niversity of Adelaide0 个研究点目标入组 28 人开始时间: 2019年1月17日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
28

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Greater than or equal to 18 years of age with a formal diagnosis of ulcerative colitis
  • Mild-moderate ulcerative colitis disease activity as defined by a Mayo Score of 3-10 with a Mayo endoscopic sub-score of greater than or equal to 1
  • Patients on stable therapy (or no therapy) for defined periods:
  • No therapy for greater than or equal to 4 weeks
  • Stable dose of oral and/or topical 5-aminosalicylic acid therapy for greater than or equal to 4 weeks
  • Stable dose of immunomodulator therapy (azathioprine, mercaptopurine, or methotrexate) for greater than or equal to 8 weeks
  • Stable dose of biologic therapy (infliximab, adalimumab, vedolizumab) for greater than or equal to 12 weeks
  • Steroid refractory – on <20mg corticosteroids for greater than or equal to 4 weeks

排除标准

  • Quiescent ulcerative colitis disease activity as defined by a Mayo Score of less than or equal to 2 and/or a Mayo endoscopic sub-score of 0.
  • Severely active UC as defined by a Mayo Score of greater than 10 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein >40, Haemoglobin <110g/l).
  • Patients with Crohn’s colitis
  • Patients who are pregnant or breast feeding
  • Patients with significant medical or cognitive/psychiatric comorbidities
  • Patients who have undergone prior colonic surgery
  • People currently receiving tapering corticosteroid therapy
  • People with evidence of active infection and/or those requiring current antibiotic therapy
  • People receiving dual antiplatelet therapy or anticoagulant therapy
  • People who are unable to provide informed consent

研究者

发起方
niversity of Adelaide

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