NL-OMON52507招募中2 期
Transfer of feces in ulcerative colitis 2; improving efficacy - TURN 2 trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >=18 and <70
- •Ability to give informed consent
- •Established ulcerative colitis with known involvement of the left colon
- •according to the Lennard-Jones criteria
- •Full Mayo score 5-9
- •Endoscopic Mayo score of >= 2 in either the rectum or sigmoid upon screening
- •sigmoidoscopy
- •Stable dose of thiopurines, 5-ASA, in preceding 8 weeks, stable budesonide
- •use in preciding 2 weeks, prednisone use <=15mg/day in preceding 2 weeks with a
- •mandatory taper of 5mg per week from week 4
- •Women need to use reliable contraceptives during participation in the study
- •* Alkaline phosphatase >1.5x ULN in the subgroup of PSC/UC patients
排除标准
- •Condition leading to profound immunosuppression
- •o For example: HIV, infectious diseases leading to immunosuppression, bone
- •marrow malignancies
- •o Use of systemic chemotherapy
- •o Child-Pugh B liver cirrhosis
- •Anti-TNF treatment in preceding 2 months
- •Vedolizumab, tofacitinib and/or ustekinumab treatment in preceding 2
- •Cyclosporine treatment in preceding 4 weeks
- •Use of Methotrexate in preceding 2 months
- •Prednisolone dose > 15 mg/day in preceding 2 weeks
- •Use of topical therapy in preceding 2 weeks
- •Life expectancy < 12 months
- •Difficulty with swallowing
- •Use of systemic antibiotics in preceding 4 weeks
- •Use of probiotic treatment in preceding 4 weeks
- •Positive stool cultures for common enteric pathogens (Salmonella, Shigella,
- •Yersinia, Campylobacter, enteropathogenic e coli)
- •Positive C. Difficile stool test
- •Positive dual faeces test for pathogenic parasites e.g. Dientamoeba
- •histolytica, Giardia Lamblia, Dientamoeba fragilis..
- •Positive serological test for HIV
- •History of surgery:
- •o presence of a pouch
- •o presence of stoma
- •Known intra-abdominal fistula
- •Pregnancy or women who give breastfeeding
- •Vasopressive medication, icu stay
- •Signs of ileus, diminished passage
- •Allergy to macrogol or substituents, eg peanuts, shellfish
- •* Allergy to gadolinium iv contrast agent in the subgroup of patients who
- •will be scheduled for MRI liver.
- •Crohn*s disease
- •* Subject who has any conditions that in the opinion of the investigator,
- •would compromise the safety of the subject or the quality of the data and is an
- •unsuitable candidate for the study
研究者
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