Treatment of Crohn’s disease-associated refractory diarrhoea with octreotide LARAn open pilot study

Gastroenterology CHC Liege0 个研究点开始时间: 2011年1月4日最近更新: 2014年2月17日

适应症

试验速览

暂无简介。

•- Patients with certain CD according to Lennard-Jones criteria
•- Patients aged 18 or older (=18 years)
•- Persisting diarrhoea, characterized by at least a mean of 5 smooth of liquid stools per day (mean of the number of stools over a one week period), despite either a normal CRP or an optimized specific treatment of CD including immunosuppressive treatment and/or infliximab
•- Diarrhoea refractory to loperamide and/or cholestyramine and requiring additional treatment with octreotide (Intention to treat the patient with octreotide)
•- For patients after a related surgical intervention, operation must be performed for a minimum of 6 months before inclusion in the trial
•- Written informed consent given
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Known allergy or intolerance to octreotide.
•- Diarrhoea due to small bowel microbial proliferation (infection).
•- Diarrhoea due to lactose intolerance
•- Diarrhoea due to irradiation
•- Diarrhoea due to chemotherapy
•- Diarrhoea due to neoplasia
•- Diarrhoea due to ischemia
•- Immediate need for surgery
•- Significant dehydration with the need for IV saline infusion
•- Severe malnutrition with a BMI <16 and the need for enteral or parenteral nutrition
•- Harvey-Bradschaw Index > 13 or with subscore for pain or general wellbeing > 2

发起方

Gastroenterology CHC Liege