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

AB Biotics

Status

Completed

Conditions

Non Alcoholic Fatty Liver

Treatments

Dietary Supplement: Probiotic composition

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04823676

ABB-MAFL21A

Details and patient eligibility

About

Some studies have shown beneficial results with probiotics on hepatic function of subjects with fatty liver, but significant variability has been noted among probiotic formulations. This study aims at providing a comprehensive characterization of the effect of a particular probiotic formula in hepatic function of said subjects.

Full description

Some studies have shown beneficial results with probiotics on hepatic function of subjects with Non-Alcoholic Fatty Liver (NAFL) also known as Metabolism-Associated Fatty Liver (MAFL). However, meta-analyses have found significant variability among probiotic formulations. In fact, many probiotic properties are thought to be strain-specific.

This study aims at providing a comprehensive characterization of a particular probiotic formula containing Lactoplantibacillus plantarum (formerly Lactobacillus plantarum) and Levilactobacillus brevis (formerly Lactobacillus brevis) in hepatic function of individuals with NAFL. The study will assess hepatic stiffness via transient elastography (Fibroscan), hepatic function via liver enzymes in serum (ALT, AST, GGT) and liver-specific inflammation via cytokeratin18 in serum, as well as some general metabolic and inflammatory markers.

Enrollment

100 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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