Clinical trial NCT05341401: Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
Official title: Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis Chronic
Keywords: ulcerative colitis.
Budesonide
prednisolone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: comparison of the efficacy of both budesonide MMX and prednisolone.
timeFrame: 8 weeks
measure: comparison of the efficacy of both budesonide MMX and prednisolone.
timeFrame: 8 weeks
measure: comparison of the efficacy of both budesonide MMX and prednisolone.
timeFrame: 8 weeks
measure: comparison of the efficacy of both budesonide MMX and prednisolone.
timeFrame: 8 weeks
Secondary outcomes:
measure: incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
timeFrame: 12 months
measure: Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: