The Effect of Dried Chicory Root on Inflammation, Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- change in fecal calprotectin
研究概览
简要总结
The goal of this clinical pilot trial is to test the use of dried chicory root in patients with IBD. The main questions it aims to answer are:
what the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber).
Researchers will compare the above mentioned outcomes before and after the intervention.
详细描述
Rationale: Inflammatory Bowel Diseases (IBD), of which Ulcerative Colitis (UC) and Crohn's Disease (CD) are the main types, includes recurring episodes of inflammation in the gastro-intestinal tract and severely impacts quality of life (QoL), leads to more hospitalization and increases the mortality risk. An impaired gut microbiota and lower levels of short-chain fatty acids (SCFA) have been linked to the pathophysiology. A higher fiber intake is linked to positive changes in the gut microbiota and increase SCFA-production, however patients with IBD consume too little dietary fiber. WholeFiberTM, a dried vegetable rich in 4 types of prebiotic fiber, may be an easy solution to increase dietary fiber intake, impact the gut microbiota and SCFA, IBD-complaints and health parameters.
Objective: To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with CD and UC.
Study design: this is a 4-week pilot study with one arm to explore the effects of a WholeFiberTM intervention. Measurements will take place before and after the intervention, questionnaires will also be conducted halfway.
Study population: in total 12 patients with mild to moderate IBD complaints will be included, of which 6 UC and 6 CD patients, to investigate if there is a difference between the two groups in efficacy of WholeFiberTM.
Intervention: Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥18 years;
- •Having a diagnosis of IBD (either UC or CD) and undergoing treatment at the policlinic at the University Medical Center Groningen;
- •Mild or moderate IBD, defined as fecal calprotectin levels ≥100 μg and Harvey Bradshaw Index (HBI) <8 for CD patients or Simple Clinical Colitis Activity Index (SCCAI) <5 for UC patients;
- •Using stable maintenance therapy for at least 12 weeks;
- •Being able to read and speak Dutch;
- •Willing to come to the University Medical Center Groningen for practical reasons (visiting the study site);
- •Willing to continue their regular lifestyle patterns during the study.
排除标准
- •Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, cancer, celiac disease;
- •Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbiota composition;
- •Having a clinically significant stenosis;
- •Use of antibiotics <4 weeks before study start;
- •Use of prebiotics, probiotics and/or synbiotic (this should be stopped 4 weeks before start of the study) or other fiber supplements such as psyllium;
- •Use of tube feeding or sib-feeding;
- •Being pregnant or lactating;
- •Participation in another clinical study at the same time;
- •Unable or unwilling to comply to study rules
研究组 & 干预措施
Before and after study in 6 patients with UC and 6 patients wiht CD
This is a 4-week before-after pilot study to explore the effectiveness of a WholeFiber Trademark (TM) intervention (a dried vegetable rich in prebiotic intrinsic fibers) on inflammation, fecal gut microbiota and metabolites, IBD-complaints and QoL and assesses its feasibility. In this before-after study, 12 patients with IBD will receive WholeFiberTM; of which 6 patients with CD and 6 patients with UC to assess if there is a difference in effect between these groups of patients.
干预措施: Dried Chicory Root (Dietary Supplement)
结局指标
主要结局
change in fecal calprotectin
时间窗: difference between baseline and after 4-week intervention
To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels in patients with CD and UC.
次要结局
- Change in IBD complaints by HBI for CD(difference between baseline and after 4-week intervention)
- Change in IBD complaints by SCCAI for UC(difference between baseline and after 4-week intervention)
- Change in QOL measured by IBDQ(difference between baseline and after 4-week intervention)
- Change in the Food-related Quality of Life (FrQOL)(difference between baseline and after 4-week intervention)
- Change in stool consistency(difference between baseline and after 4-week intervention)
- Change in stool frequency(difference between baseline and after 4-week intervention)
- Change in fecal microbiota composition by beta-diversity(difference between baseline and after 4-week intervention)
- Change in fecal SCFA levels; butyrate(difference between baseline and after 4-week intervention)
- Change in fecal SCFA levels: propionate(difference between baseline and after 4-week intervention)
- Change in fecal acidity (pH)(difference between baseline and after 4-week intervention)
- Change in serum thrombocytes(difference between baseline and after 4-week intervention)
- Change in serum iron status: Total Iron Binding Capacity (TIBC)(difference between baseline and after 4-week intervention)
- Change in serum ASAT(difference between baseline and after 4-week intervention)
- Change in inflammatory marker IL-6 analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory markers IL-12 analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory markerIL-17a analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in fecal microbiota composition: Shannon-index(difference between baseline and after 4-week intervention)
- Change in fecal SCFA levels: lactate(difference between baseline and after 4-week intervention)
- Change in C-reactive protein (CRP)(difference between baseline and after 4-week intervention)
- Change in fecal SCFA levels: formate(difference between baseline and after 4-week intervention)
- Change in serum leukocytes(difference between baseline and after 4-week intervention)
- Change in serum iron status: serum iron(difference between baseline and after 4-week intervention)
- Change in serum iron status: ferritin(difference between baseline and after 4-week intervention)
- Change in fecal SCFA levels: acetate(difference between baseline and after 4-week intervention)
- Change in fecal redox status(difference between baseline and after 4-week intervention)
- Change in serum iron status: transferrin(difference between baseline and after 4-week intervention)
- Change in serum ALAT(difference between baseline and after 4-week intervention)
- Change in serum GGT(difference between baseline and after 4-week intervention)
- Change in serum creatinine(difference between baseline and after 4-week intervention)
- Change in inflammatory marker IL-8 analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory marker IL-10 analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory marker IL-22 analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory marker IL-23 analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory marker TNF-alpha analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in inflammatory marker Interferon(IFN)-gamma analysed by an ELISA kit(difference between baseline and after 4-week intervention)
- Change in oxidative stress measured by free thiols(difference between baseline and after 4-week intervention)