Role of Probiotics in Treatment of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD) Patients by Assessing With Fibroscan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- The role of probiotics in the treatment of pediatric NAFLD by evaluating for fibrosis with a Fibroscan machine.
研究概览
简要总结
The goal of this study is to evaluate the role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis and fibrosis with a Fibroscan machine. This will be done by performing a fibroscan during each visit and comparing patients' ALT at various intervals. This is an important study as current pediatric guidelines only recommend lifestyle modifications for the treatment of NAFLD and the use of ALT and sonogram to assess improvement as standard of care. Investigators hypothesized that treatment with a probiotic will demonstrate an improvement in NAFLD as assessed by a fibroscan of liver which is good for the monitoring of steatosis and fibrosis. Additionally, analysis of fecal microbiome results may offer insight into targeted therapy in the future.
详细描述
The goal/objective of this study is to evaluate the role of probiotics in the treatment of NAFLD by assessing with fibroscan in both newly diagnosed and known pediatric patients with NAFLD. This will be done by performing a fibroscan during each visit and comparing patient ALT and fecal microbiome at various intervals.
The primary endpoint is to assess the effect of probiotic treatment in liver steatosis and fibrosis by assessing with fibroscan using CAP score and TE staging. The higher the CAP score (S1, S2, S3) so worse the steatosis. TE staging (F0-F4), higher the staging indicates worsening of fibrosis.
Secondary endpoints include:
- The rate of decline of ALT over 3 month time interval and through whole study starting at initial diagnosis.
- The rate of decrease in hepatic steatosis and BMI
This study will target pediatric patients with NAFLD. Participants will be new and previously diagnosed NAFLD patients between the ages of 5 years and 18 years.
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)
盲法说明
Participants will be blindly randomized at baseline (Visit 1) into one of two groups: probiotic or placebo. Investigators are to be blinded as well
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will target pediatric patients with NAFLD. Participants will be new and previously diagnosed NAFLD patients between the ages of 5 years and 18 years. Diagnosis must be made by elevated serum ALT (two times above the sex specific upper limit of normal) and a sonogram consistent with steatosis
排除标准
- •Exclusion criteria for both groups
- •Concomitant underlying liver disease such as but not limited to autoimmune hepatitis
- •Concomitant infectious hepatitis
- •Medication use of steroids, methotrexate, metformin, and therapeutic dose of Vit. E
- •Recent antibiotic use in last 4 weeks
- •Clinically significant weight loss (at least 5% reduction in weight from baseline level [18]) on follow up NAFLD patients who were on life style modification intervention
- •Cirrhosis (Fibroscan score ≥14.0)>
结局指标
主要结局
The role of probiotics in the treatment of pediatric NAFLD by evaluating for fibrosis with a Fibroscan machine.
时间窗: One year
The primary endpoint/outcome assesses the effect of probiotic treatment in liver fibrosis by assessing with fibroscan using TE staging.
The role of probiotics in the treatment of pediatric NAFLD by evaluating for steatosis with a Fibroscan machine.
时间窗: One year
The primary endpoint/outcome assesses the effect of probiotic treatment in liver steatosis by assessing with fibroscan using CAP score.
次要结局
- Rate of decline in ALT.(One year)
- Decrease in BMI(One year)
- Change in fecal microbiome(One year)