Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Microbial composition
研究概览
简要总结
The aims of the study are 1. to determine the effect on dysbiosis, permeability and inflammatory activity after administration of a Mediterranean like diet (a Nordic equivalent, "Nordiet"), 2. to investigate life style related factors, such as exercise, psychosexual health and quality of life and their relation to the disease activity.
详细描述
The project aims, firstly, to map the quality of life and psychosexual health of young IBD patients (18-35 years), secondly, to investigate what treatment effect a changed diet can bring, and thirdly, to investigate whether physical activity and body composition can be related to disease activity.
The investigators want to use a natural food based on Mediterranean diet without artificial additives to evaluate the effect on the degree of disease activity through analysis of customary clinical parameters such as symptom picture and lab work including calprotectin (in stool samples) but mainly analysis of the gut microbiota and bacterial DNA in the blood as a marker for intestinal health.
Physical activity can be a possible treatment. By combining activity bracelets with analysis of autonomic balance (heart rate variability) and sleep quality, examinations of symptom burden and inflammatory activity, new valuable knowledge can be obtained.
Associations have been demonstrated between active IBD, depression, stress, fatigue, quality of life and sexual function in both women and men. It is therefore important to investigate psychosexual health and quality of life among young people with IBD and to also evaluate the effects of intervention through questionnaires and qualitative interviews.
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
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBD, i.e., Mb Crohn or ulcerrative colitis
- •Moderatively active disease (calprotectin 200-600)
排除标准
- •Proctitis alone
- •Inactive disease
- •Severe flare up requiring in-patient care
- •Planned change of treatment
- •Antibiotic treatment during the last month
- •Pregnancy
- •Inability to understand Swedish
- •Multimorbidity
研究组 & 干预措施
Intervention group
Intervention where every one serves as their own control
干预措施: Nordiet (Dietary Supplement)
结局指标
主要结局
Microbial composition
时间窗: Four weeks
Gut microbiota will be analyzed at start and after four weeks. The health promoting efect of the diet will be estimated with analysis of the total bacterial genome down to species level. The bacterial composition will then be analyzed with regard to presence of beneficial or harmful bacteria. Based on the complexity of the micorbiota it is not possible to state any specific value that should be achieved.
次要结局
- Disease activity(Four weeks)