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Non Alcoholic Fatty LiverNCT04823676

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

A study testing Probiotic composition in people with Non Alcoholic Fatty Liver, run by AB Biotics, SA at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Non Alcoholic Fatty Liver
What is being tested?
Probiotic composition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteMexico
Study dates
31 Mar 2021to 22 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General Dr. Manuel Gea Gonzalez

    Mexico City, 14080

Other trials in Mexico

About this study

Official title: Efficacy and Safety of a Probiotic Composition as Adjunct Treatment in the Comprehensive Management of Metabolism-Associated Hepatic Steatosis in Adults

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.

Read the detailed 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.

Being tested
Probiotic composition, Placebo
Keywords
NAFL, MAFL
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • PlaceboOther

    Maltodextrin (E1400, qs)

Study groups in NCT04823676
Study groupRoleWhat they receive
Probiotic compositionActive comparatorA capsule containing a mix of probiotic strains (1.5 x 10^9 CFU/capsule ) administered once daily for 4 months
Receives: Dietary Supplement: Probiotic composition
PlaceboPlacebo comparatorA capsule containing placebo administered once daily for 4 months
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: change month 2 from baseline

  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

    Measured: change month 4 from baseline

Secondary outcomes (48)

  1. Change in hepatic steatosis

    Change in the severity of the degree of hepatic steatosis measured by transient elastography with controlled attenuation parameter (Fibroscan CAP®)

    Measured: change month 2 from baseline

  2. Change in hepatic steatosis

    Change in the severity of the degree of hepatic steatosis measured by transient elastography with controlled attenuation parameter (Fibroscan CAP®)

    Measured: change month 4 from baseline

  3. Change in Fibroscan-AST score

    Change in the values of the Fibroscan-AST score (FAST, ranging 0-1), where higher values indicate a worse condition

    Measured: change month 2 from baseline

  4. Change in Fibroscan-AST score

    Change in the values of the Fibroscan-AST score (FAST, ranging 0-1), where higher values indicate a worse condition

    Measured: change month 4 from baseline

  5. Change in Fatty Liver Index

    Change in the values of the Fatty Liver Index (FLI, ranging 0-100), where higher values indicate a worse condition

    Measured: change month 2 from baseline

  6. Change in Fatty Liver Index

    Change in the values of the Fatty Liver Index (FLI, ranging 0-100), where higher values indicate a worse condition

    Measured: change month 4 from baseline

  7. Change in Hepatic Steatosis Index

    Change in the values of the Hepatic Steatosis Index (HSI, ranging 0-100), where higher values indicate a worse condition

    Measured: change month 2 from baseline

  8. Change in Hepatic Steatosis Index

    Change in the values of the Hepatic Steatosis Index (HSI, ranging 0-100), where higher values indicate a worse condition

    Measured: change month 4 from baseline

  9. Change in Cholesterol

    Change in LDL cholesterol, oxidized LDL-cholesterol, HDL-cholesterol, non-HDL cholesterol, total cholesterol. Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  10. Change in Cholesterol

    Change in LDL cholesterol, oxidized LDL-cholesterol, HDL-cholesterol, non-HDL cholesterol, total cholesterol. Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  11. Change in leptin serum parameters

    Change in leptin. Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  12. Change in leptin serum parameters

    Change in leptin. Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  13. Change in adiponectin serum parameters

    Change in adiponectin. Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  14. Change in adiponectin serum parameters

    Change in adiponectin. Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  15. Change in HOMA serum parameters

    Change in HOMA (Homeostatic Model Assessment). Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  16. Change in HOMA serum parameters

    Change in HOMA (Homeostatic Model Assessment). Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  17. Change in glucose serum parameters

    Change in glucose. Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  18. Change in glucose serum parameters

    Change in glucose. Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  19. Change in glycosylated hemoglobin serum parameters

    Change in glycosylated hemoglobin (Hb1Ac). Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  20. Change in glycosylated hemoglobin serum parameters

    Change in glycosylated hemoglobin (Hb1Ac). Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  21. Change in insulin serum parameters

    Change in insulin. Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  22. Change in insulin serum parameters

    Change in insulin. Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  23. Change in Triglycerides serum parameters

    Change in Triglycerides. Sample obtained through blood sampling.

    Measured: change month 2 from baseline

  24. Change in Triglycerides serum parameters

    Change in Triglycerides. Sample obtained through blood sampling.

    Measured: change month 4 from baseline

  25. Change in ferritin serum parameters

    Change in ferritin. Samples obtained through blood sampling

    Measured: change month 2 from baseline

  26. Change in ferritin serum parameters

    Change in ferritin. Samples obtained through blood sampling

    Measured: change month 4 from baseline

  27. Change in C-reactive protein serum parameters

    Change in ferritin. Samples obtained through blood sampling

    Measured: change month 2 from baseline

  28. Change in C-reactive protein serum parameters

    Change in ferritin. Samples obtained through blood sampling

    Measured: change month 4 from baseline

  29. Change in IL-1beta serum parameters

    Change in IL-1beta. Samples obtained through blood sampling

    Measured: change month 2 from baseline

  30. Change in IL-1beta serum parameters

    Change in IL-1beta. Samples obtained through blood sampling

    Measured: change month 4 from baseline

  31. Change in TNF-alpha serum parameters

    Change in TNF-alpha. Samples obtained through blood sampling

    Measured: change month 2 from baseline

  32. Change in TNF-alpha serum parameters

    Change in TNF-alpha. Samples obtained through blood sampling

    Measured: change month 4 from baseline

  33. Change in Cytokeratin-18 serum parameters

    Change in Cytokeratin-18. Samples obtained through blood sampling

    Measured: change month 2 from baseline

  34. Change in Cytokeratin-18 serum parameters

    Change in Cytokeratin-18. Samples obtained through blood sampling

    Measured: change month 4 from baseline

  35. Change in IL-17 serum parameters

    Change in IL-17. Samples obtained through blood sampling

    Measured: change month 4 from baseline

  36. Change in IL-17 serum parameters

    Change in IL-17. Samples obtained through blood sampling

    Measured: change month 2 from baseline

  37. Intestinal microbiota composition

    Change in alpha and beta diversity of the gut microbiota as assessed by 16S bacterial gene analysis

    Measured: change month 4 from baseline

  38. Change in fat values

    Change in the values of total body fat and visceral fat evaluated by impedance measurement

    Measured: change month 2 from baseline

  39. Change in fat values

    Change in the values of total body fat and visceral fat evaluated by impedance measurement

    Measured: change month 4 from baseline

  40. Change in waist values

    Change in the values of waist circumference evaluated by impedance measurement

    Measured: change month 2 from baseline

  41. Change in waist values

    Change in the values of waist circumference evaluated by impedance measurement

    Measured: change month 4 from baseline

  42. Change in waist / height index

    Change in the values of waist / height index, evaluated by impedance measurement

    Measured: change month 2 from baseline

  43. Change in waist / height index

    Change in the values of waist / height index, evaluated by impedance measurement

    Measured: change month 4 from baseline

  44. Change in hip circumference values

    Change in the hip circumference evaluated by impedance measurement

    Measured: change month 2 from baseline

  45. Change in hip circumference values

    Change in the hip circumference evaluated by impedance measurement

    Measured: change month 4 from baseline

  46. Change in BMI values

    Change in the values of Body Mass Index (BMI) evaluated by impedance measurement

    Measured: change month 2 from baseline

  47. Change in BMI values

    Change in the values of Body Mass Index (BMI) evaluated by impedance measurement

    Measured: change month 4 from baseline

  48. Adverse events

    Frequency of adverse events

    Measured: Throughout study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start31 Mar 2021
  3. Primary completion13 Dec 2021
  4. Study completion22 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04823676
Sponsor's protocol ID
ABB-MAFL21A
Status last verified
Feb 2022
First submitted
15 Mar 2021
Last updated
24 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24187469

  • 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.

    PubMed 30113661

  • 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.

    PubMed 24912386

  • 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.

    PubMed 17081293

  • 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.

    PubMed 19766548

  • 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.

    PubMed 32027858

  • 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.

    PubMed 40568349

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic composition in people with Non Alcoholic Fatty Liver, run by AB Biotics, SA at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in alanine amino transferase (ALT) (time frame: change month 2 from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04823676, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.

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