The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy: A Single Center Randomized Open Label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
研究概览
简要总结
The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CP receiving >75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
- •Patients' insurance covers a CBTF
- •Diagnosis of cerebral palsy
排除标准
- •Receiving enteral nutrition by transpyloric feeds or jejunal tube.
- •Receiving <75% of total daily energy requirements from a commercial formula
- •Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart
- •Rapidly progressive neurodegenerative disease diagnosis
- •Use of monomeric formulas
研究组 & 干预措施
commercial blenderized tube feed (CBTF)
干预措施: commercial blenderized tube feed (CBTF) (Dietary Supplement)
commercial formulas (CF)
干预措施: commercial formulas (CF) (Dietary Supplement)
结局指标
主要结局
Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
时间窗: Baseline, end of study (2 months after baseline)
This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome.
次要结局
- Change in weight percentile(Baseline, end of study (2 months after baseline))
- Change in stool metabolomic profile(Baseline, end of study (2 months after baseline))
- Change in salivary cytokine profile(Baseline, end of study (2 months after baseline))
- Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen(Baseline, end of study (2 months after baseline))
- Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens)(Baseline, end of study (2 months after baseline))
- Change in weight(Baseline, end of study (2 months after baseline))
- Number of participants who had dose adjustments to their antacid or laxative medications(Baseline, end of study (2 months after baseline))
- Change in stool caliber using the Bristol stool scale(Baseline, end of study (2 months after baseline))
研究者
Fernando Navarro
Associate Professor
The University of Texas Health Science Center, Houston