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
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