Efficacy and Safety of a Probiotic Composition as Adjunct in MAFL Management

This is an interventional treatment trial for Non Alcoholic Fatty Liver focused on measuring NAFL, MAFL Read More

Inclusion Criteria:

• Diagnosis of Hepatic Steatosis associated with Metabolism (MAFL, also known as Non-Alcoholic Fatty Liver or NAFL) with Controlled Attenuation Parameter (CAP) value of > 269 dB / m when evaluated by Fibroscan transient elastography
• Alanine aminotransferase (ALT) levels at least 35% above the upper limit of reference values
• BMI between 25 and 40 kg / m2
• Signing of the informed consent and understanding of the procedures to be carried out
• Not willing to change their current dietary habits (hypercaloric and hyperlipemic)

Exclusion Criteria:

• Treatment of NAFL or NASH (Non-Alcoholic Steato-Hepatitis) for at least 3 months prior to the study, with high dose vitamin E (≥200 mg / day), high dose omega-3 (≥500 mg / day), pioglitazone, bile acid sequestrants, statins, GLP-1 agonists, and / or DPP4 inhibitors ("gliptins"), and not having shown a significant biochemical and ultrasonographic improvement
• History of chronic alcohol or drug abuse
• Diagnosis of infectious hepatitis or HIV infection
• Diagnosis of hemochromatosis
• Celiac disease, inflammatory bowel disease, chronic or recurrent diarrhea
• Chronic use of laxatives.
• Pancreatic failure, thyroid dysfunction, severe liver disease, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities)
• Uncontrolled diabetes or hypertriglyceridemia greater than 500mg / dL
• History of regular use (> 3 days) of oral or parenteral antibiotics one month prior to the study
• Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, monoamine oxidase inhibitors, second generation antipsychotics, amiodarone, tamoxifen, and/or diltiazem.
• Intake of other probiotics, plant-derived sterols, beta-glucans, red rice yeast (Monascus purpureus), or milk thistle extract (Silybum marianum) or its active ingredients (silymarin, silybin) on a regular basis (> 7 days) in the 15 days prior to entering the study.
• History of angina or cardiovascular events, cancer, or immunosuppression
• Chronic, moderate-to-heavy smoking (> 5 cigarettes a day)
• History of gastro-intestinal surgery in the previous year.
• Debilitating diseases (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases).
• Current pregnancy (positive urine test), or planning to become pregnant during the course of the study.
• Breastfeeding at the time of eligibility assessment
• Subjects having participated in a clinical study within 1 month prior to eligibility assessment
• Current use of 4 or more concomitant medications of any type