Study to test the efficacy of combination of a drug tofacitinib and rectal installation of faeces from healthy donors in a patient with moderate to severe ulcerative colitis

Not Applicable

• Conditions: Health Condition 1: K518- Other ulcerative colitis

• Registration Number: CTRI/2023/04/051504
• Lead Sponsor: AIIMS funding

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

8)Women of childbearing age should agree to avoid conception during the study period

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified