NL-OMON28664尚未招募不适用
Transplantation of feces in ulcerative colitis; improving efficacy
Academical Medical Center (AMC)0 个研究点目标入组 76 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
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
- •Partial mayo score of = 3 and calprotectin > 250
- •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, or budesonide in preceding 8 weeks, prednisone use =15mg/day in preceding 2 weeks, stable dose of 5-ASA or corticosteroid containing enemas in preceding 2 weeks
- •Women need to use reliable contraceptives during participation in the study
- •Alkaline phosphatase > 1.5 x ULN in the subgroup of PSC/UC patients.
排除标准
- •Condition leading to profound immunosuppression
- •For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies
- •Use of systemic chemotherapy
- •Child-Pugh B liver cirrhosis
- •Anti-TNF treatment in preceding 2 months
- •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, Blastocystis hominis only if microscopically many or very many blastocysts are seen.
- •Positive serological test for HIV
- •History of surgery:
- •presence of a pouch
- •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
- •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
- •Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver
研究者
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