Overview

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.