The Effect of Riboflavin in Crohn's Disease
关键词
抽象
描述
Rationale Recent studies show that in patients with Inflammatory Bowel Disease (IBD) a dysbiosis exists in the composition of the intestinal microbiota. In particular, the potentially pathogenic bacterium Escherichia coli (E. coli) is often more abundant in the bowel of IBD patients, and the anaerobic commensal Faecalibacterium prausnitzii (F. prausnitzii) is often reduced. This last mentioned bacteria is known to be abundant in the intestine of healthy individuals. It is known to produce butyrate, which stimulates the intestinal epithelium, and to secrete anti-inflammatory substances.
Riboflavin - also known as vitamin B2 - is required for a wide variety of cellular processes and has an important role in maintaining health in humans. In a pilot intervention with healthy volunteers it is shown that a riboflavin supplement increases the number of F. prausnitzii and results in a higher production of butyrate. In Crohn's disease patients, it is known that the amount of F. prausnitzii in the intestine is generally low. Furthermore, it is known that there is an association between the number of F. prausnitzii bacteria and the length of disease in remission.
This study will evaluate if supplementation of the diet with riboflavin in Crohn's disease patients will result in a similar increase in the amount of F. prausnitzii as in healthy volunteers. In this patient group, an increase in the number of F. prausnitzii bacteria in the bowel may result in a more favourable disease course. This will be assessed with faeces calprotectin and two questionnaires. Additionally the investigators will assess if there is any modulation by riboflavin on the other intestinal bacteria, short chain fatty acids (SCFAs) (such as butyrate), and the pH of the faeces. Finally, the effect of the riboflavin on the permeability of the gut will be evaluated with a Chroom-EDTA test, and a number of different biomarkers of permeability.
Hypothesis The hypothesis is that in Crohn's disease patients, supplementation of the diet with riboflavin results in an increase in the amount of F. prausnitzii, changes in microbial composition, increased fatty acid production, an increase in pH and a reduction of intestinal permeability. These changes might result in a more favourable disease course with less exacerbations.
Study design Prospective clinical study.
Study population and sample size In total 84 Crohn's disease patients will be included in this study, divided into two groups. Group 1 (n=42) will consist of patients with disease in remission (quiescent disease); group 2 (n=42) will consist of patients with active disease. In this study an adaptive design will be used. First 12 patients in the disease in remission group will be analysed. The methods of analysis and safety aspects will be taken into account.
Intervention Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks.
日期
最后验证: | 02/29/2020 |
首次提交: | 08/19/2015 |
提交的预估入学人数: | 08/29/2015 |
首次发布: | 09/01/2015 |
上次提交的更新: | 03/21/2020 |
最近更新发布: | 04/02/2020 |
首次提交结果的日期: | 02/29/2020 |
首次提交质量检查结果的日期: | 03/21/2020 |
首次发布结果的日期: | 04/02/2020 |
实际学习开始日期: | 02/29/2016 |
预计主要完成日期: | 03/31/2017 |
预计完成日期: | 03/31/2017 |
状况或疾病
干预/治疗
Dietary Supplement: Riboflavin supplementation
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Riboflavin supplementation in quiescent disease Group 1 (n=42) will consist of patients with disease in remission (quiescent disease). | |
Experimental: Riboflavin supplementation in active disease Group 2 (n=42) will consist of patients with active disease. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Crohn's disease patients - Age 18-65 years - Concomitant medication for Crohn's disease is allowed in all groups Exclusion Criteria: - Swallowing disorders - Pregnancy and lactation - Use of antibiotic drugs, probiotics (i.e.Yakult, Vifit, Activia etc) or specific prebiotic supplements in the 3 weeks prior to the riboflavin intervention - Use of Methotrexate drugs - Colonoscopy and colon cleansing in last 3 months - Use of a vitamin B2 supplement, or multivitamin complexes containing vitamin B (i.e. vitamin B-complex) in the 3 weeks prior to the riboflavin intervention - Severe Crohn's disease (HBI > 12) |
结果
主要结果指标
1. F. Prausnitzii (FISH Analysis). [Different time points up to 6 weeks from start study: Day0, Day7, Day28]