Micronutrient and Additive Modifications May Optimize Diet To Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Calprotectin
研究概览
简要总结
This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.
详细描述
Patients with ulcerative colitis attending the out-patient clinic at Skåne university hospital with calprotectin 100-600 will be invited to participate in this diet intervention study. They will be divided into two arms with 35 patients in each, normal diet or E-400 elimination. The diet will be recorded at study start and end with a food diary for four days and a food frequency questionnaire regarding E-400 intake. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded and microbiota collectted. The hypotheses are that the activity measured with clinical characteristics and calprotectin as well as their microboita measured with dysbiosis index and total genom with NGS will improve significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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,
- •Moderately active
- •Stable medication
排除标准
- •Severe disease
- •Recent surgery
- •Proctitis
- •Treatment with antibiotics
- •Difficulties in understanding the information about the study
- •Multimorbidity that makes it impossible to participate
研究组 & 干预措施
Normal diet
One arm will be given dietary advice that is always given to patients with ulcerative colitis.
干预措施: Normal diet (Other)
E400 elimination
The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates.
干预措施: E400 elimination (Dietary Supplement)
结局指标
主要结局
Calprotectin
时间窗: One month
A protein in faeces that increases when there is a flare of the colitis
Microbiota diversity
时间窗: One month
The diversity of the GI microbiota reflects disease severity
次要结局
未报告次要终点