Dietary Counseling Coupled With Fecal Microbiota Transplantation in the Treatment of Obesity and Non-alcoholic Fatty Liver Disease - the DIFTOB Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- A change in HOMA-IR
研究概览
简要总结
There are several studies performed to reveal the linkage between diet, fecal microbiota, and obesity. Human fecal microbiota transplantations in this asset are still scarce. Therefore, this pilot study of FMT from lean to obese people with dietary counseling will increase the knowledge, whether FMT could play a role in the treatment of obesity and NAFLD. Our primary outcome is the changes in glucose metabolism by HOMA-IR.
详细描述
The prevalence of obesity is rising. In 2015 39% of adults globally, and in 2017 25% of adults in Finland were obese (BMI ≥30kg/m2). Obesity increases the incidence of type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD).
Obesity associates with decreased gut bacterial diversity, and low microbial gene richness. The diversity of fecal microbiota composition has been shown to alter in human NAFLD. Fecal microbiota transplantation (FMT) from lean vegan donors to those with NAFLD changed fecal microbiota composition and associated with beneficial changes in plasma metabolites in a pilot randomized controlled trial.
Radiological liver imagining for NAFLD is usually performed by ultrasound. Liver elastography evaluates liver stiffness and fibrosis stage. Liver steatosis and fibrosis are known to decrease along weight loss. To our knowledge, only one small study has yet combined FMT and liver imagining in a concept of NAFLD.
Diet influences the gut microbiota. In obesity, the composition of fecal microbiota is altered. Alterations in plasma metabolites derived from gut microbiota and diet have been linked to NAFLD development. The composition of gut microbiome predicts the metabolic response to different dietary interventions in obese individuals.
The key food items of the Healthy Nordic Diet are vegetables, fruit, berries, whole grain products, fish, and rapeseed oil. Abdominal obesity was less abundant in those consuming the Healthy Nordic Diet. Dietary fiber has been associated with metabolically beneficial changes in fecal microbiome. High fat diet has been associated with worsening of fecal microbial composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
FMT is given blinded for the participant. The dieticians giving the nutritional advice are also blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥30 kg/m2
- •Age 18-75 years
- •Signed informed consent
- •Ability to take part in a group-based nutrition advice
- •Adequate Finnish comprehension (since all advice and materials are in Finnish)
排除标准
- •Unable to provide written consent
- •Attending another trial or having on-going dietary counseling at the same time
- •Pregnancy, breast feeding
- •Type I diabetes
- •Inflammatory disease
- •Liver disease other than NAFLD
- •Excess alcohol consumption (more than 20 g/day in females and more than 30 g/day in males, on average)
- •Dysmotility of upper GI-tract (e.g. gastroparesis)
- •Big hiatal hernia
- •History of a severe (anaphylactic) food allergy
- •Active, serious medical disease with likely life expectancy less than 5 years
- •Severe renal insufficiency (glomerular filtration rate <30%)
- •Procedures that have changed the anatomy of GI-tract, including obesity surgery
- •Remarkable psychiatric disorders, dementia and other diseases or conditions that could affect to the study subject´s compliance to the study
- •Systemic antibacterial treatments
- •three months before the study or during the study
- •chronic or recurrent bacterial infection for which antimicrobial medications are repeatedly used
- •Contraindication for gastroscopy
- •Central anesthesia needed for gastroscopy
- •Medications for losing weight (bupropion/naltrexon, orlistat, liraglutide)
- •Intention to obesity surgery.
- •Eligibility is evaluated by a doctor in each research unit.
结局指标
主要结局
A change in HOMA-IR
时间窗: at week 12 and at week 52
A change in HOMA-IR at week 12 and week 52 in both study groups and hypothetically more in those with FMT compared to those with placebo.
次要结局
未报告次要终点
研究者
Milla Tauriainen
MD, specialized doctor in gastroenterology and internal medicine
University of Eastern Finland