Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Brief Summary: Background/Aims:

The investigators explored the therapeutic effects of probiotics in patients with AH.

Methods:

Between September 2010 and April 2012, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after therapy.


Options:
A: Inclusion Criteria:

* Age: from 65 to 85 years
* Body Mass Index: 22-30 kg/m2
* ECOG Performance status: WHO performance score 0 to 2
* Absence of known diseases and/or abnormalities of haematological parameters (haematological, inflammatory, metabolic, hepatic and renal diseases)
* The subjects must be able to comply with management of nutraceutical products and with scheduled follow-up
* The subjects must be able to use the computer and to access to the web, by themselves or with the help of a caregiver

Exclusion Criteria:

* History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder
* Geriatric anorexia \[less than 2 full meals per day and /or less than one serving of dairy products (milk, cheese, yogurt) per day or two or more servings of legumes or eggs per week or one serving of meat, fish or poultry every day\]
* Weight loss \> 5% in the last month
* Previous antibiotic treatment within 4 months
* Active infection requiring per OS or IV antibiotics, including active tuberculosis, known and declared HIV, HCV
* Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
* Gastric disease that requires medical therapy (e.g. gastric secretion inhibitory drugs)
* Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis, diverticulosis, diverticulitis)
* Diabetes mellitus
* Dislipidemia and/or any metabolic disease that requires medical or dietetic treatment
* Myocardial infarction within 6 months prior to study entry, congestive heart disease, uncontrolled cardiac insufficiency, and any current grade 3 or 4 cardio-vascular disorder despite treatment
* Current history of neoplasm except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix and except for other cancer curatively treated and with no evidence of disease for at least 5 years
* Other sever underlying medical conditions, which could impair the ability of the patient to participate in the study
* Chronic anti-inflammatory therapy with FANS or previous therapy within 20 days from the beginning of the study. The occasional use of anti-inflammatory therapy is not an exclusion criteria, but the use is not allowed within 3 days before the analysis and for more than 8 days/2 months during the study
* Previous (within 15 days) or concomitant treatment that modifies intestinal absorption (e.g. metformine, acarbose in diabetic treatment...)
* Probiotics, prebiotics or simbiotics (yogurt or another functional foods) intake in the last 3 weeks
* Use of food supplements or functional foods such as probiotics, prebiotics, simbiotics, vitamins and minerals different than whose established in this study, is not allowed during the study period or previously within 1 week (except for vitamin D, calcium, vitamin B12)
* Total parenteral nutrition within 4 months
* History of allergy to one of the excipients present in the products under evaluation
* Concomitant or within 4 week period administration of any experimental drug, food supplements or nutraceuticals under investigation
* Subjects clearly intending to withdraw from the study if not randomised in a given arm, or subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons
* Subjects with expected non-compliance to protocol guidelines
B: 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
C: Inclusion Criteria:

* Age: from 65 to 85 years
* Body Mass Index: 22-30 kg/m2
* ECOG Performance status: WHO performance score 0 to 2
* Absence of known diseases and/or abnormalities of haematological parameters (haematological, inflammatory, metabolic, hepatic and renal diseases)
* The subjects must be able to comply with management of nutraceutical products and with scheduled follow-up
* The subjects must be able to use the computer and to access to the web, by themselves or with the help of a caregiver

Exclusion Criteria:

* History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder
* Geriatric anorexia \[less than 2 full meals per day and /or less than one serving of dairy products (milk, cheese, yogurt) per day or two or more servings of legumes or eggs per week or one serving of meat, fish or poultry every day\]
* Weight loss \> 5% in the last month
* Previous antibiotic treatment within 4 months
* Active infection requiring per OS or IV antibiotics, including active tuberculosis, known and declared HIV, HCV
* Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
* Gastric disease that requires medical therapy (e.g. gastric secretion inhibitory drugs)
* Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis, diverticulosis, diverticulitis)
* Diabetes mellitus
* Dislipidemia and/or any metabolic disease that requires medical or dietetic treatment
* Myocardial infarction within 6 months prior to study entry, congestive heart disease, uncontrolled cardiac insufficiency, and any current grade 3 or 4 cardio-vascular disorder despite treatment
* Current history of neoplasm except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix and except for other cancer curatively treated and with no evidence of disease for at least 5 years
* Other sever underlying medical conditions, which could impair the ability of the patient to participate in the study
* Chronic anti-inflammatory therapy with FANS or previous therapy within 20 days from the beginning of the study. The occasional use of anti-inflammatory therapy is not an exclusion criteria, but the use is not allowed within 3 days before the analysis and for more than 8 days/2 months during the study
* Previous (within 15 days) or concomitant treatment that modifies intestinal absorption (e.g. metformin, acarbose in diabetic treatment...)
* Probiotics, prebiotics or symbiotics (yogurt or another functional foods) intake in the last 3 weeks
* Use of food supplements or functional foods such as probiotics, prebiotics, symbiotics, vitamins and minerals different than whose established in this study, is not allowed during the study period or previously within 1 week (except for vitamin D, calcium, vitamin B12)
* Total parenteral nutrition within 4 months
* History of allergy to one of the excipients present in the products under evaluation
* Concomitant or within 4 week period administration of any experimental drug, food supplements or nutraceuticals under investigation
* Subjects clearly intending to withdraw from the study if not randomised in a given arm, or subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons
* Subjects with expected non-compliance to protocol guidelines
D: Inclusion Criteria:

* Alcoholic Hepatitis

Exclusion Criteria:

* Cancer
* Viral Hepatitis, other Hepatitis

Answer: D