Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference between the two groups in the expression of colonic (NF)-κB proteins.
研究概览
简要总结
Brief Summary:
This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- •Adults (males and/or females) with age range from 18 to 65 years old.
- •Patients on treatment with 5-aminosalisylic acid (5-ASA)
排除标准
- •Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- •Treatment with systemic or rectal steroids.
- •Treatment with immunosuppressants.
- •Previously failed treatment with a sulphasalazine.
- •Known hypersensitivity to any of study drugs.
- •Hepatic and renal dysfunction.
- •Pregnancy and lactation.
- •History of colorectal carcinoma.
- •History of complete or partial colectomy.
- •Current or previous treatment with metformin for females with polycystic ovarian syndrome.
- •Patients with diabetes mellitus
- •Patients with history of lactic acidosis
- •Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
- •Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
研究组 & 干预措施
Control group
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
干预措施: Placebo (Drug)
Metformin group
participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy
干预措施: metformin 500 mg TID Oral Tablet (Drug)
结局指标
主要结局
Difference between the two groups in the expression of colonic (NF)-κB proteins.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Doaa abdelaziz
Lecturer at pharmacy practice department, FUE, Egypt
National Hepatology & Tropical Medicine Research Institute