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

Overview

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 Title of Study: “Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: June 2023

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.

Interventions

• Drug: Budesonide MMX
  • Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
• Drug: Prednisolone
  • It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Arms, Groups and Cohorts

• Active Comparator: Budesonide MMX
  • 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.
• Active Comparator: prednisolone
  • 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 .

Clinical Trial Outcome Measures

Primary Measures

• comparison of the efficacy of both budesonide MMX and prednisolone.
  • Time Frame: 8 weeks
  • To compare: – the clinical out come(by number of bowel movement, presence or absence of blood and abdominal pain) assessment will be done at 0 ,4 weeks and after 8 weeks from treatment initiation in both groups.
• comparison of the efficacy of both budesonide MMX and prednisolone.
  • Time Frame: 8 weeks
  • To compare: – laboratory out come ( CBC,CRP and fecal calprotectin) will be done at 0,4 and 8 weeks of treatment initiation
• comparison of the efficacy of both budesonide MMX and prednisolone.
  • Time Frame: 8 weeks
  • -to compare the : endoscopic out come using mayo scoring system.
• comparison of the efficacy of both budesonide MMX and prednisolone.
  • Time Frame: 8 weeks
  • to compare the histological remission

Secondary Measures

• incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
  • Time Frame: 12 months
  • to detect the side effects reported by the patients in each group and compare them to each other.
• Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
  • Time Frame: 12 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Assiut University
• Provider of Information About this Clinical Study
  • Principal Investigator: Ghada Mohammed Kamal Eldin Mohammed Ali, principle investigator – Assiut University
• Overall Contact(s)
  • Ghada M.Kamal Ali, PHD, 01008800296, Ghada.Elefaai@gmail.com