NCT05615779招募中不适用
The Fibre Study: RCT of Personalized Fibre Diet in IBD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Diet tolerability
研究概览
简要总结
This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children (age 6-17) or young adults (age 18-39).
- •Known or suspected UC or IBDU [there will be 2 control group: non-IBD (undergoing colonoscopy but found not to have IBD; and healthy (no GI symptoms, so not required to have colonoscopy; could be family members)]
- •For UC: Remission-mild-moderate disease: Mayo score <10
- •Clinical indication for sedated colonoscopy
- •Disease location: E2-E4
- •Stable treatment (not on steroids; biologics or immunomodulator not changed in last month)
- •High likelihood that patients will be able to collect all samples and provide all data
排除标准
- •Use of antibiotics for a week or more over the last 3 months
- •Use of probiotics or prebiotics at pharmacological doses (adding fibre sources to food or probiotics in yogurt, for example, are allowed)
- •History of abdominal surgery, including appendectomy
- •Documented enteric infection during the 3 months prior to endoscopy
- •Presence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorder
- •Presence of a systemic disease requiring treatment (cancer, ischemic heart disease, kidney failure, etc)
- •Proctitis (E1)
- •Systemic steroids (above 10 mg/day of Prednisone)
- •Topical therapy within 1 week of endoscopy
- •Recent change in IBD treatment (started biologics or IM over the last month)
- •Pregnancy or planning to become pregnant during the study
- •Inability to understand or sign the consent
结局指标
主要结局
Diet tolerability
时间窗: 4 weeks
Percentage of patients able to tolerate a personalized fiber diet provided by a dietitian will be evaluated at week 4 by measure of patient symptom score (PROMIS questionnaire) and willingness to continue adherence to diet advice provided.
次要结局
- Inflammatory response to diet(1 week, 4 weeks, 8 weeks, 12 weeks)
- Microbiota changes in response to diet(1 week, 4 weeks, 8 weeks, 12 weeks)
研究者
研究点 (4)
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