A randomized controlled trial of nutrition with and without corticosteroids in acute severe ulcerative colitis
Not Applicable
Completed
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2020/06/025989
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
1.Patients presented with Acute Severe Ulcerative Colitis as defined by Truelove and Wittâ??s criteria.
2.Patients who have not received any dose of steroid or other immune-suppressive therapy for this episode from outside.
3.Patients giving written informed consent
Exclusion Criteria
1. Age < 18 years, >75 years.
2. Patients with indeterminate form of colitis or crohnâ??s colitis.
3. UC patients with infection related flares (like CMV or C. difficile infection)
4. Patients with infective colitis or colitis of other etiologies.
5. ASUC patients having toxic megacolon, paralytic ileus or perforation.
6. Pregnancy
7. Other major co-morbid conditions like acute myocardial infarction, chronic kidney disease or chronic liver disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) Proportion of patients requiring colectomy in both the groups. <br/ ><br>b) Proportion of patients requiring medical rescue therapy in both the groups <br/ ><br>c) Proportion of patients who have complete response and partial response to iv steroid on day 7 of treatment. <br/ ><br>Timepoint: 7 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method a) Changes in fecal calprotectin and serum CRP level after 3rd day of treatment in both the groups. <br/ ><br>b) Changes in body weight, serum albumin level in both the groups at the end of follow up (Day 7) <br/ ><br>c) Treatment related adverse events in both the group. <br/ ><br>Timepoint: 7 days