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

Assiut University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Ulcerative Colitis Chronic

Treatments: Drug: Budesonide MMX; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05341401

Budesonide in UC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Budesonide MMX

Active Comparator group

Description:

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.

Treatment:

Drug: Budesonide MMX

prednisolone

Active Comparator group

Description:

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 .

Treatment:

Drug: Prednisolone