A Randomized Controlled Trial Evaluating the Efficacy of a Combination of Tofacitinib and Fecal Microbiota Transplantation (FMT) versus Tofacitinib and Sham Transplantation in Inducing Remission in Patients with Moderate to Severe Ulcerative Colitis

AIIMS funding0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

暂无简介。

•1)Patients with moderate to severe (as defined by SCCAI score >6) endoscopically active UC (UCEIS >1)
•2)Patients giving written informed consent
•3)Patients who are steroid dependent or refractory
•4)Patients who are thiopurine failure or intolerant
•5)Anti-TNF naÃ¯ve or experienced (intolerant or non-responder) but last dose >=2 months back
•6)Anti-integrin naÃ¯ve or experienced (intolerant or non-responder) but last dose >=2 months back
•7)Concomitant therapy allowed-
•a.Topical steroid and topical 5-ASA therapy (if stable for last 2 weeks)
•b.Oral corticosteroids (Prednisone equivalent up to 20 mg/day; budesonide up to 9 mg/day. Stable dose for at least 2 weeks prior to baseline period. Budesonide tapering 3mg every 3weekly and prednisolone tapering 5mg every 2 weekly),
•c.Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks
•8)Women of childbearing age should agree to avoid conception during the study period

•1)Age <18 years, >65 years
•2)Patients with acute severe ulcerative colitis
•3)Clinical signs of fulminant colitis or toxic megacolon
•4)Indeterminate, ischemic, infectious or Crohnâ??s colitis
•5)UC limited to distal 15 cm of colon
•6)Received no treatment for UC in past i.e., treatment-naÃ¯ve
•7)Patients who are steroid naÃ¯ve
•8)If subject have received the following therapy-
•a.Intravenous corticosteroids within 2 weeks prior to baseline
•b.Anti-TNF therapy (e.g., infliximab, adalimumab, or certolizumab) within 8 weeks prior to baseline
•9)Pregnancy and lactation
•10)Concomitant Clostridioides Difficile infection
•11)Severe comorbid medical illness
•a.Cardiac: NYHA II or higher congestive heart failure
•b.Renal: Creatine clearance (Cockcroft Gault formula) <40 ml/min
•c.Severe hepatic impairment
•d.Malignancies or a history of malignancies
•e.Significant trauma or major surgery within 4 weeks
•f.History of bowel surgery within 6 months
•12)Contraindication to Tofacitinib including
•a.Severe hepatic impairment:
•b.Hepatitis B, C
•c.Active TB
•d.H/O DVT or thrombotic disorder

发起方

AIIMS funding