Rifaximin-treatment of Collagenous Colitis:
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 主要终点
- Clinical remission
研究概览
简要总结
The hypothesis of this study is that an altered gut microbiota is a contributory factor in initiating an inflammatory process in the colonic mucosa leading to collagenous colitis. The investigators suggest that treatment with budesonide reduces the inflammation without treating the underlying cause. In this trial the investigators will try to modullate gut microbiota by adding rifaximin. The aim of this study is to assess if 4 weeks treatment with rifaximin as a supplement to a standard course of budesonide against active CC can reduce the risk of relapse after treatment cessation.
详细描述
Patients with biopsy-verified CC and active disease defined by >3 bowel movements/day or >1 watery stool measured as a mean for a week. Patients will be invited to participate in the study independently of age and disease duration.
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)
盲法说明
Randomisation and labelling follow guidelines defined by the Danish Medicines Agency and will be performed by the Hospital Pharmacy Region Midtjylland Clinical Trial Unit, Aarhus University Hospital and Norgine. For equal allocation to the two treatment arms computer generated block randomisation (blocks of 8) will be performed
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
- •• Signed informed consent
- •Histological findings fulfill criteria for CC:
- •A subepithelial collagenous band >10 μm in colonic biopsies
- •Increased count of inflammatory cells in lamina propria
- •Diagnostic biopsies are a maximum of two years old
- •A history of nonbloody, watery diarrhea for more than two weeks prior to screening in patients with recently diagnosed CC or a history of clinical relapse for more than a week in patients with known CC
- •Active disease: > 3 stools/day or >1 watery stool/day measured as a mean during a week prior to baseline
排除标准
- •- Significant findings at colonoscopy that could cause diarrhea (colonic diverticulosis and polyps < 2 cm are not considered significant findings)
- •Biopsies more than two years old in a patient, who does not accept a new sigmoidoscopy
- •Untreated celiac disease
- •Positive stool cultures for pathogenic intestinal bacteria including Clostridium difficile
- •Suspected colitis induced by medication (diarrhea shortly after commencement of NSAID's, statins, SSRI or PPI)
- •Severe comorbidity (cardiovascular, renal, endocrine, neurologic, pulmonal or psychiatric) or history of cancer during the last 5 years
- •Abnormal liver biochemistry (ALAT or ALP > 2,5 x upper limit), cirrhosis or portal hypertension
- •Pregnancy or lactation (assured by negative P-hCG at inclusion)
- •History of significant intestinal resection
- •Treatment with 5-ASA, Salazopyrin, immunemudulators (Azathioprine, 6-mercaptopurine or Methotrexate), biologic drugs (TNF-alfa-inhibitors), local or systemic glucocorticoids (except for Budesonide) within the last three month
- •Allergy or intolerance to Rifaximin (or similar antibiotics such as Rifampicin or Rifabutin)
- •Expectation of lack of cooperation or insufficient comprehension
- •Concomitant participation in an other clinical trial or participation within the last 30 days
- •Patients receiving Warfarin or Marcoumar (interaction with risk of uncontrolled INR-levels)
研究组 & 干预措施
Placebo
Placebo TID for 4 weeks
干预措施: Rifaximin 550 MG (Drug)
Rifaxamine 550 mg
Study drug Oral Rifaximin 550 mg TID for 4 weeks .
干预措施: Rifaximin 550 MG (Drug)
结局指标
主要结局
Clinical remission
时间窗: The number of patients in clinical remission 12 weeks after randomisation
The number of patients in clinical remission in the Rifaximin group compared to the placebo group.
次要结局
- Time to relapse.(Last visit is one year after treatment cessation.)
- Difference in Quality of life: short health scale (SHS)(12 weeks after treatment)
- Microbioma(12 weeks after treatment)