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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
It is a corticosteroid used as a standard therapy for management of ulcerative colitis
comparison of the efficacy of both budesonide MMX and prednisolone.
To compare: \- the clinical out come(by number of bowel movement, presence or absence of blood and abdominal pain) assessment will be done at 0 ,4 weeks and after 8 weeks from treatment initiation in both groups.
Time frame: 8 weeks
comparison of the efficacy of both budesonide MMX and prednisolone.
To compare: \- laboratory out come ( CBC,CRP and fecal calprotectin) will be done at 0,4 and 8 weeks of treatment initiation
Time frame: 8 weeks
comparison of the efficacy of both budesonide MMX and prednisolone.
-to compare the : endoscopic out come using mayo scoring system.
Time frame: 8 weeks
comparison of the efficacy of both budesonide MMX and prednisolone.
to compare the histological remission
Time frame: 8 weeks
incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
to detect the side effects reported by the patients in each group and compare them to each other.
Time frame: 12 months
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Time frame: 12 months
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