NCT05998213已完成2 期
Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2020年6月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Clinical and endoscopic remission
研究概览
简要总结
The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis.
Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas).
Donors are selected based on microbiota profile.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 or , 5-ASA, or budesonide in preceding 8 weeks.
- •Stable dose of budesonide in preceding 2 weeks.
- •Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week
- •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-TNFα treatment in preceding 2 months
- •Vedolizumab treatment in preceding 2 months
- •Tofacitinib treatment in preceding 2 months
- •Ustekinumab 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
- •Known allergy to iv gadolinium in the subgroup of patients who would 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
结局指标
主要结局
Clinical and endoscopic remission
时间窗: week 8
per adapted Mayo: stool frequency subscores (SFS) ≤ 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore ≤ 1. The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score. A higher score reflects worse outcome.
次要结局
- Endoscopic response, evaluated by sigmoidoscopy(week 8)
- Clinical response(week 8)
- Clinical improvement(week 8)
- Clinical remission(week 8)
- Complete remission(week 8)
- Sustained steroid-free remission(week 52)
- Endoscopic complete remission(week 8)
- Endoscopic improvement(week 8)
- Histological remission(week 8)
- SCCAI(week 1, 2, 3, 4, 8, 18, 39, and 52)
- Partial Mayo score(week 1, 2, 3, 4, 8, 18, 39, and 52)
- IBD-Control(week 2, 4, 8, 18, 39, and 52)
- Adverse events(week 8)
研究者
Cyriel Y Ponsioen
prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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