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
- 4
- 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
- •I. Is able to provide informed consent. II. Is over the age of 18 years. III. Has a diagnosis of ulcerative colitis or Crohn's disease for over a 3-month duration that was confirmed by a specialist gastroenterologist IV. Pro-6 score of 2 to 4, partial mayo 3-6 (mild to moderate UC) or Harvey Bradshaw Index (HBI) 5 to 15 (Crohn's disease)
- •V. Medications:
- •Oral 5-Aminosalicylates: If taking an oral 5-Aminosalicylates the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
- •Oral Corticosteroids: If taking oral corticosteroids the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit at a dose of ≤30mg.
- •Oral Azathioprine/6MP, Methotrexate or tacrolimus: If taking one of these medications the patient has used them for a minimum of 12 weeks and has been on a stable dose for 4 weeks prior to screening.
- •Biologic therapy with infliximab, adalimumab or vedolizumab: If taking one of these medications the patient has used them for a minimum of 12 weeks
- •Rectal Preparations; 5-Aminosalicylates, corticosteroids or tacrolimus: If taking one of these medications the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
- •VI. Willing to participate in the study and comply with the proceedings by signing a written informed consent.
- •VII. Free of any clinically significant disease, other than ulcerative colitis/Crohn's disease, that would interfere with the study's evaluations.
- •VIII. Subjects can read and understand English and is able to adhere to the study methodology and visit schedules.
排除标准
- •I. Has been on antibiotics within the last four weeks. II. Has a known food allergy to nuts, soy, eggs or dairy. III. Is pregnant or breast feeding. IV. Following a vegetarian, vegan or low FODMAP diet. V. Has known dementia and the inability to understand the trial requirements. VI. Ulcerative colitis: Patients with less than 15cm of disease (proctitis) VII. Crohn's disease: Patients with severe Disease (HBI > 15) or remission (HBI<5) VIII. Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease (Boneh et al, 2017)
研究组 & 干预措施
Intervention Group
Patients will follow a lacto-ovo vegetarian diet for an 8 week period. patients will be provided with a lacto-ovo vegetarian food box delivery service with fresh ingredients and recipes to cover four dinners per week.
干预措施: Lacto-ovo vegetarian diet (Other)
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 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)
- Number of participants with a change in beneficial gut metabolome profile at week 8(Week 8)
- Number of participants with changes to IBDQ score at week 8(Week 8)
- Participants SF-36 quality of life score at week 8(Week 8)
研究者
Charlene Grosse
Advanced Accredited Practising Dietitian, PhD Candidate
Edith Cowan University