Diet Treatment of Patients With Ulcerative Colitis in Remission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Gastrointestinal symptoms
研究概览
简要总结
The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.
详细描述
Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".
Symptom reports, blood, and fecal samples are collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
- •ROM IV criteria fullfilled
- •Stable medical therapy
排除标准
- •Intake of a low FODMAP diet within the past 6 weeks prior to baseline
- •Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless normal sigmoidoscopy
- •If diarrhea: Clostridium difficile infection
- •Lactose intolerance
- •Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
- •Antibiotics within 6 weeks
- •Pregnancy
- •Activity in UC
- •Coeliac disease
- •Abnormal transglutaminase
- •Eating disorder
- •Special diet preventing the low FODMAP diet
- •Other GI disease or other disease explaining symptoms
- •Medication intake explaining symptoms
- •Not able to follow protocol
结局指标
主要结局
Gastrointestinal symptoms
时间窗: Week 8
IBS-SSS questionnaire
次要结局
- Change in Quality of life(Week 8)
- Pain diary(Daily during the study)
研究者
Anne Lund Krarup
MD, PhD
Regionshospital Nordjylland