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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Budesonide; Prednisolone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.