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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Alcoholic Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Active and placebo capsules are indistinguishable in form, color and taste, and provided in coded boxes. List containing the correspondence between codes and treatment group assignment is prepared by a pharmacist not participating in the study and kept in a sealed envelope until the end of the study.

Study Groups

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Probiotic composition

A capsule containing a mix of probiotic strains (1.5 x 10\^9 CFU/capsule ) administered once daily for 4 months

Group Type ACTIVE_COMPARATOR

Probiotic composition

Intervention Type DIETARY_SUPPLEMENT

Mixture of two Lactoplantibacillus plantarum strains (formerly Lactobacillus plantarum) and one Levilactobacillus brevis strain (formerly Lactobacillus brevis), in a maltodextrin carrier (E1400)

Placebo

A capsule containing placebo administered once daily for 4 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Maltodextrin (E1400, qs)

Interventions

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Probiotic composition

Mixture of two Lactoplantibacillus plantarum strains (formerly Lactobacillus plantarum) and one Levilactobacillus brevis strain (formerly Lactobacillus brevis), in a maltodextrin carrier (E1400)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin (E1400, qs)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No