Status:
UNKNOWN
Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
Lead Sponsor:
Assiut University
Conditions:
Ulcerative Colitis Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- This study will include patients with confirmed mild to moderate ulcerative colitis according to the Mayo score activity index with ages ranging between 18-60 years old.
Exclusion
- Patients \< 18 years old.
- Pregnant females.
- Patients with proven infection with any enteric pathogens (e.g., Shigella species, Clostridium species, Salmonella species, ova, parasites, Clostridium difficile toxins A or B, or HIV infection).
- Patients who received oral or rectal steroids in the last 4 weeks, immunosuppressive agents in the last 8 weeks, or anti-tumor necrosis factor agents in the last 3 months.
- Patients with severe colitis (Mayo score \>11); Patients with evidence or history of toxic megacolon.
- Severe anemia (hemoglobin \<10.5 g/dl), leucopenia, or granulocytopenia.
- Patients using any cytochrome P450 inducers or inhibitors (e.g., ketoconazole, phenytoin) or antibiotics.
- Patients with renal disease/insufficiency.
- Patients with type I diabetes.
- Patients with glaucoma.
- Patients with malignancies.
- Patients with decompensated liver cirrhosis (Child-Pugh score B and C).
- Patients with COVID 19 infection.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05341401
Start Date
June 1 2022
End Date
June 1 2024
Last Update
April 22 2022
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