Rifaximin-treatment of Collagenous colitis: A prospective, double-blind, placebo-controlled study

XiCoCo study group0 个研究点目标入组 48 人开始时间: 2018年8月2日最近更新: 2021年12月13日

适应症

试验速览

暂无简介。

•Age >18 years
•Written informed consent
•Histological findings fulfill criteria for CC:
•oA thickenened subepithelial collagenous band >10 µm in veloriented colonic biopsies and
•oIncreased 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•-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, immunomudulators (Azathioprine, 6-mercaptopurine or Methotrexate), biologic drugs (TNF-alfa-inhibitors), systemic or rectal administered 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)

发起方

XiCoCo study group