Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percent Change in Alanine Aminotransferase (ALT) Level
研究概览
简要总结
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in treatment compared to placebo.
详细描述
This is a randomized, double blind, placebo controlled, three month treatment trial of children aged 6-19 years. Participants will be recruited from the Children's Healthcare of Atlanta pediatric liver clinical practice.The purpose of this study is to evaluate if a three month treatment with IMM-124E (a bovine colostrum enriched with anti-LPS antibodies) in combination with standard of care lifestyle advice is safe and leads to greater improvement in hepatic inflammation, insulin sensitivity, and blood lipids in children with nonalcoholic fatty liver disease (NAFLD) compared to placebo with standard of care treatment. Investigators also seek to define the mechanism of action in response to three months of treatment with IMM-124E.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonalcoholic fatty liver disease (NAFLD) diagnosis confirmed by liver biopsy or MRI
- •ALT ≥ 2 x ULN at screening (girls ≥ 46, boys ≥ 54)
- •Written informed parent consent and child assent
- •Willingness to take IMM-124E or placebo powder 3 x daily for 12 weeks
- •At least 2 months of attempted lifestyle changes after diagnosis
排除标准
- •Disease or condition deemed by physician to interfere with absorption, digestion, or mechanism of intervention of drug
- •Diagnosis of diabetes and an HbA1c of > 9%
- •Change in supplement or anti-oxidant therapy within past 90 days (must be on a stable dose and willing to continue it throughout the trial or not on any vitamin or supplement, includes SAMe, vitamin E, betaine, Milk thistle etc)
- •Use of probiotics or antibiotics in the past 30 days
- •Use of anti-NAFLD medications (metformin, thiazolidinediones, UDCA) in the 30 days prior to randomization
- •Acute illness within past 2 weeks prior to enrollment (defined as fever > 100.4ºF)
- •Planned pregnancy, nursing an infant, confirmed or suspected to be pregnant between screening and time of study enrollment
- •Evidence of other chronic liver disease other than NAFLD (Hepatitis B and C, Alpha-1 antitrypsin, Wilson's disease)
- •Intolerance to lactose or dairy-based products
- •Unable to have blood drawn at study visits
- •Unwillingness to provide and/or collect stool samples
- •Current gastrointestinal (GI) bleeding or inflammatory bowel disease (irritable bowel disease (IBD), colitis)
- •Current enrollment in another therapeutic clinical trial or receipt of an investigational study drug within 6 months prior to study enrollment
- •Participants who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
结局指标
主要结局
Percent Change in Alanine Aminotransferase (ALT) Level
时间窗: Baseline (Week 0), End of Treatment (Week 12)
Percent change in ALT level from baseline to end of treatment.
次要结局
- Change in Fasting Insulin Level(Baseline (Week 0), End of Treatment (Week 12))
- Change in Insulin Levels(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in Fasting Glucose Level(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in Waist Circumference(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in Blood Glucose Level(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in Hepatic Fat Percent(Baseline (Week 0), End of Treatment (Week 12))
- Change in Hemoglobin A1C Level(Baseline (Week 0), End of Treatment (Week 12))
- Change in Adipose Tissue Insulin Resistance (Adipo-IR)(Baseline (Week 0), End of Treatment (Week 12))
- Change in Triglyceride/HDL (TG/HDL) Ratio(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in Body Mass Index (BMI) Z-Score(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in Visceral Adiposity(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in PROMIS Fatigue Questionnaire Score(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in PROMIS Anxiety Questionnaire Score(Baseline (Week 0), End of Treatment (Week 12))
- Percent Change in PROMIS Depression Questionnaire Score(Baseline (Week 0), End of Treatment (Week 12))
- Composite Metabolic Improvement(End of Treatment (Week 12))
研究者
Miriam Vos, MD
Associate Professor
Emory University