Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Prednisolone: Oral prednisolone 40 mg initially will continued for 2 weeks thereafter will be tapered 10 mg weekly till 6 weeks followed by matching placebo for 4 weeks in short taper a
Sponsors
Amol N Patil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Evidence of active ulcerative colitis as defined by the Mayo score of > 2 (with endoscopic score of at-least 2) 2. Initiated on steroids for disease activity as per clinicians judgement 3. Evidence of clinical response to steroids, as evidenced by reduction in stool frequency (reduction by 50%) with disappearance (or marked reduction) of visible blood by 2 weeks
Exclusion criteria
Exclusion criteria: 1. Age less than 12 years 2. Contraindication to steroids 3. Unwilling to participate and follow up 4. Exclusion of infectious exacerbation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rates of disease remission after six months of steroid initiation by Mayo score.Timepoint: Baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare safety of steroid tapering regimen in ulcerative colitis patients 2. To compare the changes in fecal microbiome 3. To compare mucosal healing by UCEIS scoring system 4. To compare Histologic changes by Nancy Index scoring systemTimepoint: Safety: Baseline, 3 months and 6 months Fecal Microbiome: Baseline, 3 months and 6 months UCEIS score: Baseline and 6 months Nancy index score: Baseline and 6 months | — |
Countries
India
Contacts
Public ContactAnkit Kumar
PGIMER Chandigarh
Outcome results
None listed