Use of a Novel Diet (UC Diet) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Clinical Remission
研究概览
简要总结
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.
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
- 8 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Established diagnosis of UC
- •Age: 8-19 (inclusive)
- •Mild to moderate active disease, 10<PUCAI<45
- •Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks.
- •Participant has agreed to follow the UCD for 12 weeks
排除标准
- •Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks
- •Antibiotic or corticosteroid use in the past 2 weeks
- •Use of biologics in present or in the past
- •PUCAI>45
- •Acute severe UC in the previous 12 months
- •Current extra intestinal manifestation of UC
- •Primary Sclerosing Cholangitis (PSC) or liver disease
- •Pregnancy
- •Known food allergy to mandatory foods in the UCD
结局指标
主要结局
Clinical Remission
时间窗: At 6 weeks following enrollment
Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)
次要结局
- Change in C-reactive protein (CRP) between baseline and week 12(12 weeks)
- Change in fecal calprotectin (FCP) between baseline and week 12(12 weeks)
- Dietary Compliance(Up to 12 weeks following enrollment)
- Change in erythrocyte sedimentation rate (ESR) between baseline and week 12(12 weeks)
- Microbial composition of the gastrointestinal tract(12 weeks)