Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- comparison of the efficacy of both budesonide MMX and prednisolone.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Budesonide MMX (Drug)
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 .
干预措施: Prednisolone (Drug)
结局指标
主要结局
comparison of the efficacy of both budesonide MMX and prednisolone.
时间窗: 8 weeks
to compare the histological remission
次要结局
- Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis(12 months)
- incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis(12 months)
研究者
Ghada Mohammed Kamal Eldin Mohammed Ali
principle investigator
Assiut University