NCT01477307已完成不适用
Effect of Dietary Intervention on Intestinal Microbiota in Patients With Non-alcoholic Fatty Liver Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- abundance of fecal abundance of fecal Bacteroidetes
研究概览
简要总结
In patients with NAFLD/NASH, changes in liver lipid composition and function tests following a short dietary intervention are associated with changes in gut microbiota
详细描述
Study Hypothesis: In patients with NAFLD/NASH, changes in liver lipid composition and function tests following a short dietary intervention are associated with changes in gut microbiota
Study period:
- Study duration for the participant: 7-10 weeks (1-4 weeks screening period, 3 weeks of intervention + 3 weeks of follow-up)
- Expected study completion date: 30.04.2012 Study type: Single arm before-after study
Number of patients:
20 subjects with obesity and NAFLD / NASH
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity defined as BMI>30 Abnormal liver function tests defined as ALT > 1.5 times the upper limit of normal NAFLD present at liver biopsy Age > 18 years, < 60 years
排除标准
- •Inability or unwillingness to give consent Bulimia Other known cause of chronic liver disease, including hepatitis B or C, iron overload, Use of substances known to alter intestinal permeability, including alcohol and NSAIDs
结局指标
主要结局
abundance of fecal abundance of fecal Bacteroidetes
时间窗: thrice, at inclusion, day 21 and day 42
Bacterial cells/g caecal content
次要结局
- body composition(thrice, at inclusion, day 21 and day 42)
- Breath test pullulation(twice, at inclusion and day 21)
- serum LPS(twice, at inclusion and day 21)
- intestinal permeability(twice, at inclusion and day 21)
- liver fat content(twice, at inclusion and day 21)
- liver function tests(four times, at screening, inclusion, day 21 and day 42)
- CRP(thrice, at screening, inclusion and day 21)
- serum cytokines(twice, at inclusion and day 21)
- liver lipid composition (biopsy)(once, at screening)
研究者
Prof. Claude Pichard
Head, Clinical Nutrition
University Hospital, Geneva
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver DiseaseNon-alcoholic Fatty Liver Disease (NAFLD)Non-alcoholic Steatohepatitis (NASH)NCT01894438Harokopio University63
招募中
不适用
Impact of Time-restricted Feeding in NAFLDFatty Liver, NonalcoholicFatty Liver DiseaseFatty LiverNCT05220956Johannes Gutenberg University Mainz100
进行中（未招募）
不适用
Intestinal Microbiota and NAFLD Pre and Post Bariatric SurgeryMorbid ObesityNon-alcoholic Fatty Liver DiseaseNCT01856465Johane Allard120
Unknown
不适用
Micro RNA Levels in NAFLDNon-Alcoholic Fatty Liver DiseaseNCT04574557Assiut University80
已完成
不适用
Effect of Mediterranean Diet on Non-alcoholic Fatty Liver DiseaseNAFLDNCT01798719Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis50