Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.
Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with age above 18 years old
- •Patient with diagnosis of ulcerative colitis for at least 6 months.
- •Patient with mayo endoscopic score ≥ 1
- •Patient with mild to moderate disease activity (3 < SCCI < 12)
- •Ongoing treatment by mesalamine, steroids, thiopurines or Tumor Necrosis Factor antagonist at stable dose.
- •Patients who have given written informed consent.
排除标准
- •Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
- •Psychiatric disease that alter the judgment
- •Proctocolectomy
- •Severe disease (SCCI >12, acute severe colitis)
- •Steroid dose > 10 mg/j or introduction of steroid (topic or oral) within 4 weeks
- •Introduction or dose optimization of TNF antagonist within 4 months
- •Introduction or dose optimization of thiopurine
- •Hemoglobin level < 11,5 g/dL, Platelets > 400000/mm3, Leukocytosis > 10 000/mm3
- •Intolerant to lactose
- •Disease extent limited to the rectum
- •Mayo endoscopic subscore of 3
结局指标
主要结局
Response rate
时间窗: Week 8
Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)
次要结局
- Rate of clinical remission(Week 8)
- Rate of mucosal healing(Week 8)
- Rate of clinical response(Week 4)
- Rate of deep (clinical and endoscopic) remission(Week 8)
- Side effects(Week 8)
- Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0(Week 8)
- Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0(Week 8)