ACTRN12624000916549尚未招募Unknown
Investigating a novel therapeutic diet on food additives for ulcerative colitis in adults - The INNOVATE Study
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 32
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •mild to moderate ulcerative colitis
- •- active disease (either left-sided or extensive UC) as evidenced sonographically, faecal calprotectin >250 and where available, endoscopy results performed in the last 3 months indicate total Mayo score of 3-10
- •- on stable medical therapy for >1 month
- •- naïve to formal dietetic intervention
排除标准
- •- Severe UC, indeterminate colitis or Crohn’s disease
- •- Presence of other GI co-morbidities (e.g. coeliac disease)
- •- Presence of clinically significant haematological abnormalities
- •- Prior gastrointestinal surgeries
- •- Pregnancy, trying to get pregnant and breastfeeding
- •- Current use of corticosteroids
- •- Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g. food allergy, veganism, lacto-ovo vegetarianism)
- •- Individuals not on a stable diet for at least 4 weeks
研究者
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