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

Last updated: April 17, 2022
Sponsor: Assiut University
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT05341401
Budesonide in UC
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • This study will include patients with confirmed mild to moderate ulcerative colitisaccording to the Mayo score activity index with ages ranging between 18-60 years old.

Exclusion

Exclusion Criteria:

  • Patients < 18 years old.
  • Pregnant females.
  • Patients with proven infection with any enteric pathogens (e.g., Shigellaspecies, Clostridium species, Salmonella species, ova, parasites, Clostridiumdifficile 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 factoragents in the last 3 months.
  • Patients with severe colitis (Mayo score >11); Patients with evidence or historyof 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.

Study Design

Total Participants: 100
Study Start date:
June 01, 2022
Estimated Completion Date:
June 30, 2024

Study 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.