A randomised controlled trial comparing FMT (Fecal Microbiota Transplantation) after budesonide or placebo in patients with active ulcerative colitis

Vedanta0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Patients > 18 years old (n=24) with mild or moderate activity of ulcerative colitis despite previous maintenance therapy (mesalazine, or thiopurine, or anti-TNF) with a MA YO endoscopic score of I or lI.

•CMV infection, pregnancy, recent use (<6 weeks) of antibiotics, recent (<2 months) use of oral corticosteroids, current need for systematic antibiotics or prophylactic antibiotic, recent intraabdominal surgery (<3 months), signs of active active infectious gastro-enteritis/enterocolitis or signs of infectious agents in stool sample, previous surgery for UC, abnormal renal function (eGFR <30ml/min), pre-existent leucopenia or thrombopenia (leucocyte count <2,000/mm3, or platelets <90,000/mm3, liver function tests abnormalities (>2 ULN), treatment with any investigational drug in another trial within 12 weeks of randomization, previous treatment with >2 biologicals, other significant medical illness that might interfere with this study.

发起方

Vedanta