Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Multi-ingredient probiotic capsules: One capsule twice daily for 90 days
Control Intervention1: Placebo capsules which are identical to intervention capsules without active ingredients:
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 with a significant history of drug or alcohol abuse Patients who have used dietary supplements rich in omega 3 or omega 6 fatty acids, probiotics, homeopathic or herbal drugs in the 4 weeks prior to baseline. Patients who have participated in any other clinical study with an investigational drug within 3 months Patients who are pregnant, planning pregnancy, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the change in liver fat between the two groups after 90 days of treatment and change in serum ALT (alanine aminotransferase) from baseline to Day 90 Timepoint: Baseline and EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to 90 days in AST (aspartate aminotransferase) AST and ALT ratio FIB 4 Index NAFLD fibrosis score (NFS) HOMA IR (Homeostatic model assessment Insulin Resistance) Change in liver enzymes and lipid parameters Oxidative stress parameters ( catalase, SOD,GSHPx,iNOS, MDA and DPPH scavenging activity) Change in glycemic parameters in fasting conditions Change in biomarkers of inflammation (hsCRP, IL6, IL8,TNF alpha, NF kB) Change in anthropometric parameters â?? Timepoint: Baseline and EOT | — |
Countries
India
Contacts
Public ContactDrJayanthi Neelamraju
Unique Biotech Limited
Outcome results
None listed