The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks
研究概览
简要总结
The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with small intestinal Crohn's disease.
详细描述
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark.
The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon.
CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear.
A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation.
The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with small intestinal CD
- •Fecal calprotectin ≥ 250 ug/g
- •IUS evidence of small bowel inflammation with wall thickness ≥ 4 mm
- •At least 3 months af stable medical treatment
- •Able to read and speak Danish
排除标准
- •Positive rectal swab for pathogenic microorganisms
- •Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
- •Participation in other clinical trials within 30 days prior to inclusion
- •Pregnancy, planned pregnancy or breast feeding
- •Psychiatric disease
- •Abuse of alcohol or drugs
结局指标
主要结局
Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks
时间窗: 8 weeks
IUS will be performed in the non-fasting patient lying in supine position with a high-end ultrasound machine (Siemens Sequoia) with 10L4 transducer.
次要结局
- The change from baseline on Color Doppler Imaging Score (0-3) including inflammatory fat and ulceration (yes/no) at 8 weeks(8 weeks)
- Change in severity of symptoms from baseline measured by Harvey-Bradshaw index (HBI) at 8 weeks(8 weeks)
- Change in quality of life from baseline measured by Inflammatory Bowel Disease Questionnaire (IBDQ) Questionnaire Scores at 8 weeks(8 weeks)
- Change in fecal calprotectin level from baseline at 8 weeks(8 weeks)
- Adverse and severe adverse events(16 weeks)
研究者
Andreas Munk Petersen
Principal Investigator, MD, PhD
Hvidovre University Hospital