Sodium Butyrate Effectiveness in Children and Adolescents With Newly Diagnosed Inflammatory Bowel Diseases - Randomized Placebo-controlled Multicentre Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- difference in remission rate (PUCAI ulcerative colitis)
研究概览
简要总结
The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.
详细描述
Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD.
This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 to 18 years of age;
- •newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
- •informed consent of the child's parents or guardians to participate in the study.
排除标准
- •age <6 years;
- •taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
- •lack of consent of parents or guardians to participate in the study.
结局指标
主要结局
difference in remission rate (PUCAI ulcerative colitis)
时间窗: 12 weeks
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measured in points of activity was used to assess UC activity. Severity of the disease: \<10 points = remission 10-34 points = mild ulcerative colitis 35-64 points = moderate ulcerative colitis ≥65 points = severe ulcerative colitis In this scale addominal pain (mild or moderate/severe), number of stools per day, blood in the stool, stool consistency, nocturnal stools and activity level (no limitation, occasional or restricted), are assessed. The scale is validated and used in daily clinical practice. Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
difference in remission rate (PCDAI for Crohn's disease)
时间窗: 12 weeks
The Pediatric Crohn's Disease Activity Index (PCDAI) measured in points of activity was used to assess CD activity. Severity of the disease: \<10 points = remission 10-27.5 points = mild Crohn's Disease 30-37.5 points = moderate Crohn's Disease ≥40 points = severe Crohn's Disease In this scale addominal pain (mild or moderate/severe), number of stools per day, general well being (good, below par, very poor), antropometric measures, palpable mass in the abdomen and perianal fistulas are assessed. The scale is validated and used in daily clinical practice. Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
次要结局
- difference in disease activity for CD and UC patients(12 weeks)
- difference in calprotectin concentration(12 weeks)
- side effects(12 weeks)