Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fecal calprotectin reduction
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. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
详细描述
GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.
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
- 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
- •Age 18 years or more
- •Diagnosed ulcerative colitis
- •Signs of clinical activity with SCCAI of 3 or more
- •Extension more than 10 cm and no more than 40 cm from anus
排除标准
- •Rectal temperature more than 38 degrees Celcius
- •Diagnosed celiac disease or lactose intolerance
- •Unable to speak or understand Danish
- •Prior biologics or systemic steroids 4 weeks up to inclusion
研究组 & 干预措施
CGMP protein
Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose
干预措施: CGMP protein (Drug)
Standard oral 5ASA maximal dose
Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)
干预措施: Maximal oral 5ASA (Drug)
结局指标
主要结局
Fecal calprotectin reduction
时间窗: 4 weeks
Relative reduction in fecal calprotectin measured before and after 4 weeks
次要结局
- Clinical activity index(4 weeks)
- Quality of life(4 weeks)
- Endoscopic Mayo score(4 weeks)
- Serial fecal calprotectin(8 weeks)