Förändrat Livsmedelsval Vid Inflammatorisk Tarmsjukdom
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Region Skane
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Concentration of calproteictin
研究概览
简要总结
The goal of this clinical trial is to increase the knowledge on what type of diet affects inflammation and how to better convay that information in patients with inflammatory bowel disease (IBD) and decrease selective eating in patients with IBD. The main questions it aims to answer are:
- will the use of calprotectin as a control for changes in inflammation decrease selective food choices?
- will the use of a digital information tool increase quality of life (QoL) och decrease selctive eating patterns?
- will a diet based on nordic food choices decrease inflammation and increase QoL?
Researchers will compare with IBD-patients in ordinary care.
Participants will eat a test diet during six weeks or go through a digital information tool.
详细描述
Patients with inflammatory bowel disease attending the out-patient clinic at Skåne university hospital with calprotectin 200-600 will be invited to participate in this diet intervention study. They will be divided into four arms with 35 patients in each, normal diet, test diets or diet with digital information tool.
The diet will be recorded at study start and end with a food diary for four days, as will health related quality of life. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Although the patients know that they will be given dietary advice they will not know what type of intervention the other group will be offered. Since dietary advice must be given by the investigators the study cannot be blinded to them.
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
- •Ulcerative colitis and Crohn's disease
- •Calprotectin 200-600
排除标准
- •Non-active disease
- •solely procitis
- •Severe disease
- •past extensive bowel surgery
- •treatment with antibiotics (last month or present)
- •pregnancy
- •unability to understand spoken or written Swedish
- •Multimorbidity which aggrevate participation
研究组 & 干预措施
Normal diet
Test diet calprotectin
干预措施: Diet (Other)
Test diets Nordic
干预措施: Diet (Other)
Digital information tool
干预措施: education (Other)
结局指标
主要结局
Concentration of calproteictin
时间窗: From enrollment until 6 weeks
次要结局
- Four days registrered food intake(At beginning and after 6 week)