Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis
研究概览
简要总结
The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.
详细描述
Liver-related mortality is increased 10-fold in NASH patients compared with the general population. Currently, there are no established pharmacotherapies for NASH patients. The gut microbiota has a major contributing role in the development of NASH with leaky gut, inflammation, oxidative stress and impaired microbiota. Restoring the microbiota symbiosys could be a new way of resolution of NASH.
The aim of this trial is to evaluate the efficacy of the Combo, association of probiotics (Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum) and Glutamine, Quercetin, Vitamin E, Curcumin, Silybin, Pectin by means of histological resolution of NASH without progression of fibrosis, after 26 weeks (6 months), in 60 NASH patients with mild to severe fibrosis.
To confirm a histological diagnosis of NASH and proof efficacy of the Combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe NASH :
- •chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects
- •metabolic syndrome
- •liver stiffness assessed by FibroScan between 8 and 15kPa
- •Affiliated to a social security
- •Women using effective contraception (hormonal or mechanical) for the duration of the srudy
排除标准
- •Pregnancy
- •Excessive alcohol consumption (>100g/week)
- •Cirrhosis (elastometry > 15kPa)
- •hepato-cellular carcinoma
- •Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen
- •Viral hepatitis
- •Auto immune hepatitis
- •anticoagulant therapy
- •antibiotics in the month prior to inclusion
- •allergic to soya, aspirin, fish, E110 dye, Maltodextrin
- •poorly controlled diabetes (Glycated Hemoglobin >8%)
- •inclusion in a drug interventional trial
结局指标
主要结局
NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis
时间窗: At 6 months
Evolution of the SAF score and CAP elastometry, a composite histological score taking into account the improvement of Steatosis, histological activity and liver fibrosis
次要结局
- Follow up of transaminase levels(At 6 months)
- Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).(At the screening)
- Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI(At 6 months)
研究者
Hervé Hagege
Pr
Centre Hospitalier Intercommunal Creteil