Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of participants with negative C. difficile stool
研究概览
简要总结
The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Clostridium Difficile Infection.
For this study, the investigators will be looking to determine:
- Is SCD effective for the treatment for Clostridium Difficile Colonization?
- Is the SCD well tolerated?
详细描述
The aim of this study is to determine the tolerability and potential efficacy of dietary therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with persistent antigen positivity due to C. difficile colonization with minimally active symptomatology. The goal of this pilot study is to gather preliminary data for a future treatment controlled trial of SCD versus standard medical therapy.
This is a single center, open labelled study designed to determine tolerability, preliminary safety and potential efficacy in pediatric patients with persistent C. difficile colonization with minimally active symptomatology. The study patients will be recruited from Seattle Children's Gastroenterology and Infectious Disease clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents eighteen months old to twenty one years old
- •Diagnosis of C. difficile based upon stool antigen and toxin
- •Minimally active symptomatology based upon
- •4 or less stools per day
- •No evidence of dehydration
- •No evidence of bandemia or hypoalbuminemia on screening labs
- •Parent/guardian and child must be able to comprehend the consent and assent
- •Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +
- •Patient must not have had antibiotic treatment directed at C. difficile for at least 1 week.
排除标准
- •Severe symptoms
- •Abdominal pain that interrupts or inhibits normal activity
- •Blood in stool
- •Clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, and cystic fibrosis
- •Tobacco, alcohol or illicit drug abuse
- •Currently taking antibiotics at time of enrollment
- •Malnutrition as judged by the ratio of weight to height,
- •Clinical signs of dehydration(CD score>0)
结局指标
主要结局
Number of participants with negative C. difficile stool
时间窗: 12 weeks
Stool is analyzed for C. difficile antigen and toxin by enzyme-linked immunosorbent assay (EIA). Samples that are antigen positive and toxin negative by EIA screen will be analyzed by the more sensitive polymerase chain reaction amplification (PCR) assay to detect C. difficile toxin.
Number of participants able to maintain the specific carbohydrate diet
时间窗: 4 weeks
Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet.
次要结局
未报告次要终点
研究者
David Suskind
Professor of Pediatrics
Seattle Children's Hospital