Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Brief Summary: To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Options:
A: Inclusion Criteria:

* Age 18 to 70 years
* Fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging
* Elevated alanine aminotransferase (ALT) according to Prati's criteria (\>30 IU/l in men and \>19 IU/l in women)18
* Written informed consent obtained

Exclusion Criteria:

* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
* Alcohol consumption above 30 g per week in men or 20 g per week in women
* ALT above 10 times the upper limit of normal
* Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
* Use of systemic corticosteroids and methotrexate in the last 6 months
* Evidence of hepatocellular carcinoma
* Terminal illness or cancer, unless in complete remission for more than 5 years
B: Inclusion Criteria:

* Biliary atresia patients aged 0 to 3 years, who had a Kasai operation

Exclusion Criteria:

* The patients who had received liver transplantation
C: Inclusion Criteria:

* Must sign an Informed Consent Form
* In remission from past HE
* Uses appropriate birth control measures
* More than or equal to 18 years of age
* Must have potential to benefit from treatment
* Recent prior HE episodes
* Capable and willing to comply with all study procedures
* Participant has personal support available
* Has a certain Model End Stage Liver Disease (MELD) score
* Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision

Exclusion Criteria:

* Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include
* Allergies to the study drug or similar drugs
* Laboratory abnormalities
* Recent participation in another clinical trial
* History of non-compliance
* Pregnant or at risk of pregnancy, or is lactating
* Recent alcohol consumption
* Active bacterial or viral Infections
* Bowel issues
* Active malignancy
* On a prohibited medication
* Liver transplant expected in near term
* Lactulose intolerance
* Participant shows presence of intestinal obstruction or has inflammatory bowel disease
* Ongoing or recent GI bleed
D: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome

Answer: D