NCT05341401

Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis

Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

My study aims to directly compare the efficacy and safety of Budesonide MMX versus Prednisolone in the management of mild to moderate cases of ulcerative colitis.

Detailed description

It is a randomized clinical trial where patients with mild to moderate ulcerative colitis who failed to respond to conventional therapy with mesalazine will randomly be divided into two groups one of them will be given prednisone and the other will be given budesonide MMX. The efficacy of Budesonide MMX and Prednisolone will be measured by the rate of clinical, laboratory, endoscopic, and histological improvement 8 weeks after randomization. Clinical assessment (the rate of bowel movements and rectal bleeding) and laboratory investigations ( complete blood count \[CBC\], C reactive protein\[CRP\], and fecal calprotectin) will be done after 4 and 8 weeks from treatment initiation. Endoscopic and histological assessments will be done at week 8.

Conditions

• Ulcerative Colitis Chronic

Interventions

Type	Name	Description
DRUG	Budesonide MMX	Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
DRUG	Prednisolone	It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2022-04-22
• Last updated: 2022-04-22