A double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of UB-ABC in adults with nonalcoholic fatty liver disease (NAFLD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine the change in liver fat between the two groups after 90 days of treatment and
研究概览
简要总结
Non-Alcoholic Fatty Liver Disease (NAFLD) is a condition characterized by the accumulation of fat in the liver, which can lead to inflammation and liver damage. There have been a few studies wherein they have been found to be efficacious in the management of NAFLD . Imbalances in the gut microbiome, have been linked to the development and progression of NAFLD. Probiotics help restore a healthy balance of gut bacteria, reducing the influx of harmful substances from the intestines into the liver Moreover certain probiotics demonstrate anti-inflammatory properties.and by reducing systemic and liver-specific inflammation, probiotics may mitigate the damage caused by inflammation in the liver.
In this double blind, randomized study, the efficacy of probiotic consumption for 90 days as compared to placebo will be studied in the management of NAFLD and its symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Early diagnosis of NAFLD grading 1 2or 3 on abdominal ultrasound Mild to moderate elevation of serum aminotransferase levels Treatment naïve patients or patients not on any treatment for at least 4 weeks before inclusion Patients with a body mass index between 25 and 40 kg per square meter Patients with a history of controlled obesity or controlled diabetes.
排除标准
- •Patients with an unstable metabolic condition such as weight change of more than 5 percent in the 3 months prior to inclusion Patients with medical history of gastric bypass surgery or orthotopic liver transplant Patients with uncontrolled diabetes mellitus type 2 at the time of screening Patients with decompensated or severe liver disease as evidenced by one or more of the following, confirmed cirrhosis or suspicion of cirrhosis, esophageal varices, ascites, suspicion of portal hypertension, hospitalization for liver disease within 60 days of screening.
- •Patients with inflammatory bowel disease Patients with diagnosed or suspected autoimmune diseases Patients with a history of or active non liver malignancies Patients with a significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis Patients requiring anti-diabetic treatment or lipid lowering treatment If patients are insulin dependent this treatment should have commenced at least 3 months prior to screening however changes in dose are permitted.
- •Patients with known hypersensitivity to any ingredients of the study treatment.
- •Patients with a positive test for human immunodeficiency virus antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
- •Patients with liver disease of other etiologies such as drug induced, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alpha1 antitrypsin deficiency or Wilsons disease.
- •Patients who have participated in any other clinical study with an investigational drug within 3 months Patients who are pregnant, planning pregnancy, breastfeeding.
结局指标
主要结局
To determine the change in liver fat between the two groups after 90 days of treatment and
时间窗: Baseline and EOT
change in serum ALT (alanine aminotransferase) from baseline to Day 90
时间窗: Baseline and EOT
次要结局
- Change from baseline to 90 days in(AST (aspartate aminotransferase))
研究者
Dr Mahesh Talekar
Anupama Research Foundation