Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Clinical remission rate
研究概览
简要总结
Patients with IBD are randomized to oral administration of VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients.
详细描述
Inflammatory bowel disease (IBD) is a group of chronic idiopathic inflammatory intestinal diseases, mainly including ulcerative colitis and Crohn's disease, with increasing incidence in China and worldwide. The disease currently lacks a cure, with many patients experiencing relapses and requiring surgery, and an increased risk of cancer. There is substantial evidence suggesting a close relationship between body vitamin B6 levels and IBD.Thus,we design this clinical trial that aims to explore whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect.
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)
盲法说明
Double-blind randomized controlled trial involving patients and healthcare providers
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI: 10.19538/j.nk2018090106);
- •Have complete medical history data;
- •Volunteer to participate in this clinical trial and sign the informed consent form.
排除标准
- •Patients with peripheral neuropathy;
- •Patients with abdominal abscess, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
- •Patients with other autoimmune diseases, hematologic disorders, tumors, acute infections, severe liver or kidney dysfunction, severe conditions such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, and psychiatric disorders;
- •Patients who have taken vitamin B6 tablets in the past 3 months;
- •Patients with a history of substance abuse;
- •Pregnant or lactating women, or those planning to become pregnant within the next 6 months;
- •Neurological disorders such as Alzheimer's disease, stroke, Parkinson's disease;
- •Participation in other clinical trials in the past 6 months;
- •Incomplete medical records (including gender, age, diagnosis, colonoscopy results, pathological diagnosis results, and other demographic data);
- •Currently taking: levodopa, phenobarbital, phenytoin sodium.
研究组 & 干预措施
Experimental：VitaminB6 group
Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks.
干预措施: Vitamin B6 Tablets (Drug)
Experimental：VitaminB6 group
Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks.
干预措施: Placebo (Drug)
Placebo Comparator:Control group
Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks.
干预措施: Vitamin B6 Tablets (Drug)
Placebo Comparator:Control group
Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical remission rate
时间窗: Through study completion, an average of 6 months .
To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAl score\<150) in IBD patients after 3 weeks of oral Vitamin B6 while taking routine treatment.
次要结局
- Clinical response(Through study completion, an average of 6 months .)
- Histological remission(Through study completion, an average of 6 months .)
- Disease activity score of IBD patients(Through study completion, an average of 6 months .)