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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide MMX | Active Comparator | this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. Budesonide MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The dose will be 9mg as a single dose given for 8 weeks. |
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| prednisolone | Active Comparator | this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. prdinisolone MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The starting dose will be 40 mg and reduced by 5 mg each weak for 8 weeks . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide MMX | Drug | Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 8 weeks |
| comparison of the efficacy of both budesonide MMX and prednisolone. | -to compare the : endoscopic out come using mayo scoring system. | 8 weeks |
| comparison of the efficacy of both budesonide MMX and prednisolone. | to compare the histological remission | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis |
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Inclusion Criteria:
Exclusion Criteria:
Patients < 18 years old.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada M.Kamal Ali, PHD | Contact | 01008800296 | Ghada.Elefaai@gmail.com |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Prednisolone | Drug | It is a corticosteroid used as a standard therapy for management of ulcerative colitis |
|
| 12 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |