CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Fecal inflammatory marker
研究概览
简要总结
Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (verified by mucosal histology and endoscopy)
- •Clinically active ulcerative colitis (SCCAI ≥ 3)
排除标准
- •Endoscopically inactive disease (Endoscopic Mayo Score of 0)
- •Lactose or milk protein intolerance
- •Celiac disease
- •Not able to understand or speak Danish.
- •Pregnant or nursing.
- •Growth of pathogenic bacteria in stool culture from 4 weeks before and until randomization (Salmonella, Campylobacter, Yersinia or Clostridium Difficile.)
结局指标
主要结局
Fecal inflammatory marker
时间窗: 12 weeks
The number of patients with a fecal-calprotectin below 150 mg/kg
Endoscopic remission
时间窗: 12 weeks
The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0)
Clinical remission
时间窗: 12 weeks
The number of patients in clinical remission (SCCAI ≤ 2)
Clinical Response
时间窗: 12 weeks
The number of patients with clinical response (reduction of SCCAI-score of at least 2 points)
次要结局
- Clinical remission at follow-up(26 weeks)
- Endoscopic response(12 weeks)
- Steroid-free remission(12 weeks)