NCT04823676

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

March 15, 2021

Last Update Submit

February 23, 2022

Conditions

Non Alcoholic Fatty Liver

Keywords

NAFLMAFL

Outcome Measures

Primary Outcomes (2)

  • Change in alanine amino transferase (ALT)

    Change in serum levels (international units/L) of alanine amino transferase (ALT) across the study. Sample obtained through blood sampling

    change month 2 from baseline

  • Change in alanine amino transferase (ALT)

    Change in serum levels (international units/L) of alanine amino transferase (ALT) across the study. Sample obtained through blood sampling

    change month 4 from baseline

Secondary Outcomes (48)

  • Change in hepatic steatosis

    change month 2 from baseline

  • Change in hepatic steatosis

    change month 4 from baseline

  • Change in Fibroscan-AST score

    change month 2 from baseline

  • Change in Fibroscan-AST score

    change month 4 from baseline

  • Change in Fatty Liver Index

    change month 2 from baseline

  • +43 more secondary outcomes

Study Arms (2)

Probiotic composition

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic composition

Placebo

PLACEBO COMPARATOR

A capsule containing placebo administered once daily for 4 months

Other: Placebo

Interventions

Probiotic compositionDIETARY_SUPPLEMENT

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

Probiotic composition
PlaceboOTHER

Maltodextrin (E1400, qs)

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, 14080, Mexico

Location

Related Publications (7)

  • Ma YY, Li L, Yu CH, Shen Z, Chen LH, Li YM. Effects of probiotics on nonalcoholic fatty liver disease: a meta-analysis. World J Gastroenterol. 2013 Oct 28;19(40):6911-8. doi: 10.3748/wjg.v19.i40.6911.

    PMID: 24187469RESULT

  • Loman BR, Hernandez-Saavedra D, An R, Rector RS. Prebiotic and probiotic treatment of nonalcoholic fatty liver disease: a systematic review and meta-analysis. Nutr Rev. 2018 Nov 1;76(11):822-839. doi: 10.1093/nutrit/nuy031.

    PMID: 30113661RESULT

  • Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.

    PMID: 24912386RESULT

  • Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. doi: 10.1186/1471-230X-6-33.

    PMID: 17081293RESULT

  • Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.

    PMID: 19766548RESULT

  • Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.

    PMID: 32027858RESULT

  • Aghara H, Patel M, Chadha P, Parwani K, Chaturvedi R, Mandal P. Unraveling the Gut-Liver-Brain Axis: Microbiome, Inflammation, and Emerging Therapeutic Approaches. Mediators Inflamm. 2025 Jun 18;2025:6733477. doi: 10.1155/mi/6733477. eCollection 2025.

    PMID: 40568349DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

April 1, 2021

Study Start

March 31, 2021

Primary Completion

December 13, 2021

Study Completion

February 22, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)