Efficacy of a Lacto-ovo Vegetarian Diet in Mild to Moderate IBD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Number of participants with a clinical response at week 8
研究概览
简要总结
To determine whether a lacto-ovo vegetarian diet is effective in improving gastrointestinal symptoms, quality-of-life, intestinal inflammation and gut microbiota composition in mild-to-moderate IBD compared to a standard omnivorous diet.
详细描述
This study will review whether a lacto-ovo vegetarian diet is an optimal dietary therapy to achieve a clinical response in mild to moderate UC and CD as an adjunctive treatment to current medical therapies. The proposed studyT will be used to evaluate the efficacy of a lacto-ovo vegetarian diet together with its effect on the microbiota to create an enhanced understanding of the role diet plays in the management midl to moderate IBD. Using a socially acceptable diet it is anticipated that food-related quality-of-life measures will improve for participants. Dietary modification could be a more economical, safer and more effective means of reducing symptoms and flare-ups compared to pharmacological therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of this type of dietary intervention it is not possible to blind the participant nor treating gastroenterolgist
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with a clinical response at week 8
时间窗: Week 8
A clinical response is defined as a decrease from baseline in the total Mayo score of at least three points, with an accompanying decrease in the subscore for rectal bleeding or at least 1 point or an absolute subscore for rectal bleeding of 0 or 1
次要结局
- Number of participants achieving clinical remission at week 8(Week 8)
- Number of participants with changes to IBDQ score at week 8(Week 8)
- Number of participants achieving a change in gut microbiome diversity at week 8(Week 8)
- Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8(Week 8)
- Participants SF-36 quality of life score at week 8(Week 8)
- Number of participants with a change in beneficial gut metabolome profile at week 8(Week 8)
研究者
Charlene Grosse
Advanced Accredited Practising Dietitian, PhD Candidate
Edith Cowan University