CTRI/2023/04/051504
Not yet recruiting
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AIIMS funding
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 naïve or experienced (intolerant or non\-responder) but last dose \>\=2 months back
- •6\)Anti\-integrin naïve 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
Exclusion Criteria
- •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\-naïve
- •7\)Patients who are steroid naïve
- •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
Outcomes
Primary Outcomes
Not specified
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