2024-517132-22-00招募中3 期
Multicenter, prospective, double-blind, randomized, three-armed, placebo-controlled study of long-term therapeutic transfer of encapsulated stool microbiome for the treatment of active ulcerative colitis
Friedrich-Schiller-Universitaet Jena21 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年11月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 21
- 主要终点
- clinical remission at week 12 post transfer defined by Mayo score ≤ 2 and any subcore ≤ 1, missing values to week 12 are considered as no remission
研究概览
简要总结
clinical efficacy of long-term transplantation of capsules with faecal microbiota and faecal microbiota filtrate
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •written consent
- •prior endoscopic confirmation of colitis ulcerosa (first diagnosis of at least 6 months, active disease: mayo score between 4-10 points at screening, documented endoscopic minimum disease extent of 15 cm from the anal verge (mayo endoskopic subscore >1)
- •Failure of conventional therapy or treatment with biologicals and/or small molecules
- •previous medical therapy: -oral 5-ASA compounds (5-ASA) (stable dose for 4 weeks before randomisation) OR -Azathioprine, 6-MP or MTX (stable dose for 8 weeks before randomisation) OR -oral steroid therapy: (prednisone (≤ 20 mg/day) or budesonide (≤ 9 mg/day)) (stable dose for 2 weeks before randomisation) OR -topical therapy (foams, clysms) with mesalazine or budesonide (stable dose for 2 weeks before randomisation)
- •previous vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology
- •Ability to understand study procedures and willingness to meet requirements associated with participation (e. g. endoscopy, intake antibiotics)
- •potentially childbearing patient: negative pregnancy test and use of a highly effective contraceptive method
排除标准
- •Crohn´s disease, indeterminate colitis or ulcerative proctitis (< 15 cm ab ano)
- •lack of immunity to SARS-CoV-2
- •Previous treatment with TNF-, IL12/IL23-, IL23- or integrin-antibodies (8 weeks before randomisation)
- •Treatment with calcineurin inhibitors (4 weeks before randomization)
- •Treatment with JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) (4 weeks before randomization)
- •Treatment with S1P receptor modulator (e. g. ozanimod, etrasimod) (4 weeks before randomization)
- •Systemic antibiotic treatment (8 weeks before randomization)
- •Known intolerance to metronidazole or vancomycin
- •Participation in a clinical trial (3 months before randomization)
- •Previous FMT or FMFT, previous participation in this study (screening allowed)
- •Use of probiotics in tablet, capsule, or powder form, or appropriate drinking yogurts (or similar) (2 weeks before randomization)
- •Acute abdomen or other clinical emergencies (toxic megacolon, fulminant gastrointestinal hemorrhage, ileus, perforation, etc.)
- •Failure to ensure frozen storage of investigational products: no possibility to store capsules at ≤ -10°C, planned longer absence (12 weeks after randomization)
- •Addictive or other medical conditions or circumstances that do not allow the subject to appreciate the nature, significance, scope, and possible consequences of the clinical trial
- •Indications that the patient would be unlikely to comply with the protocol (e.g., unwillingness to cooperate - compliance questionable)
- •Previous operations on the colon: colectomy, partial colon resections
- •current gastrointestinal infections (e. g. Clostridium difficile infection, CMV infection) until randomisation
- •Congenital or acquired immunodeficiency
- •severe comorbidity (e.g. insulin-dependent diabetes mellitus, decompensated liver cirrhosis, primary sclerosing cholangitis, renal impairment > grade 2)
- •diagnosis of a malignoma in the last 3 years
- •refusal of endoscopies with video documentation
- •No specific therapy for ulcerative colitis to date
结局指标
主要结局
clinical remission at week 12 post transfer defined by Mayo score ≤ 2 and any subcore ≤ 1, missing values to week 12 are considered as no remission
clinical remission at week 12 post transfer defined by Mayo score ≤ 2 and any subcore ≤ 1, missing values to week 12 are considered as no remission
次要结局
- - steroid-free clinical remission
- - Mayo score
- - endoscopic remission
- - clinical response
- - mucosal infammation (fecal calprotectin)
- - histological mucosal inflammation (Nancy index)
- - quality of life
- - microbiome and virome analysis
- - safety
研究者
Prof. Dr. Andreas Stallmach
Scientific
Friedrich-Schiller-Universitaet Jena
研究点 (21)
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