Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2020-04-04
• Target enrollment: 0
• Participant gender: All

Summary

The study is planned as a randomised control trial to study the adjuvant use of antibiotics (ceftriaxone and metronidazole) to achieve a clinical response in hospitalised patients with acute severe ulcerative colitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ceftriaxone; Metronidazole

Criteria

Inclusion Criteria:

• Acute severe ulcerative colitis as described in European Crohn's and Colitis Organisation (ECCO) guidelines (adapted from Truelove and Witts)

Exclusion Criteria:

• Patients who deny consent

• Age<=12 years

• Pregnant or lactating women

• Severe uncontrolled comorbidities like diabetes mellitus, hypertension, coronary artery disease, chronic liver disease, chronic kidney disease, etc

• History of antibiotic use in the past one month, excluding those who may have received a single dose of antibiotic in past 24 hrs

• History of hypersensitivity or contraindication to steroids or the test drugs

• Presence of toxic megacolon as defined by transverse colon diameter more than 5.5cm on abdominal X-ray

• Patients with evidence of sepsis or active infection