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Fatty Liver, NonalcoholicNCT06491342

Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease

A study testing Probiotic in people with Fatty Liver, Nonalcoholic, run by Phramongkutklao College of Medicine and Hospital at 2 sites in Thailand.

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

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Fatty Liver, Nonalcoholic
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesThailand
Study dates
25 Jul 2024to 28 May 2025
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 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Supplement with probiotic/prebiotic within 2 weeks
  • Previous antibiotic/antifungus within 1 month
  • History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
  • Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
  • Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
  • Hepatic decompensation or impairment defined as presence of any of the following:
Show all 17Show fewer
  • History of esophageal varices, ascites or hepatic encephalopathy.
  • Serum albumin <3.5 g dl-1, except as explained by nonhepatic causes.
  • INR > 1.4
  • Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
  • Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
  • Active malignancy on treatment
  • New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction <30%
  • Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
  • Respiratory compromised
  • Severe renal impairment (eGFR <30 ml/min/1.73 m2)
  • Pregnancy

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Chiangmai university

    Chiang Mai, 50200

  • Division of gastroenterology and hepatology

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

Official title: PROBIOTIC SUPPLEMENT VERSUS PLACEBO FOR DECREASE STEATOSIS IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE (MASLD): A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Read the detailed description

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, fibroscan and metabolic profile

Being tested
Probiotic, Placebo
Keywords
Probiotic
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.

  • ProbioticDietary supplement

    Probiotic-Lactobacillus Zeae and Lactobacillus reuteri

  • PlaceboDietary supplement

    placebo

Study groups in NCT06491342
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMaltodextrin in bovine gelatin capsule look same as probiotic (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner
Receives: Dietary Supplement: Placebo
probioticActive comparatorLactobacillus Zeae and Lactobacillus reuteri probiotic mixed with Maltodextrin in ratio 15:85 in bovine gelatin capsule (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner (1,000 mg =1x109 CFU/g)
Receives: Dietary Supplement: Probiotic

What is being measured

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

  1. Liver steatosis by fibroscan

    Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m)

    Measured: 12 weeks

  2. Liver steatosis by MRI

    Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent

    Measured: 12 weeks

  3. Liver stiffness by fibroscan

    Fibroscan- transient elastography in kilopascals (kPa)

    Measured: 12 weeks

Secondary outcomes (10)

  1. Liver inflammation

    Evaluated alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L)

    Measured: 12 weeks

  2. Metabolic profile

    Fasting plasma glucose (FPG) in mg/dL

    Measured: 12 weeks

  3. Metabolic profile

    HbA1C in percent

    Measured: 12 weeks

  4. Metabolic profile: HOMA IR

    Fasting plasma glucose and serum insulin level will be combined to report in HOMA IR in mg/dl x mIU/L

    Measured: 12 weeks

  5. Metabolic profile: serum lipid profiles

    Total cholesterol in mg/dL, low-density lipoprotein (LDL) cholesterol in mg/dL, high-density lipoprotein (HDL) in mg/dl, cholesterol in mg/dL, and triglyceride in mg/dL

    Measured: 12 weeks

  6. Inflammatory marker

    hsCRP level in mg/L

    Measured: 12 weeks

  7. Inflammatory marker

    Interleukin 6 (IL-6) in pg/mL

    Measured: 12 weeks

  8. Anthropomorphic evaluation: BMI

    Weight and height will be combined to report BMI in kg/m^2

    Measured: 12 weeks

  9. Anthropomorphic evaluation: composition analysis

    Body fat in percentage

    Measured: 12 weeks

  10. Anthropomorphic evaluation

    Body muscle in kilogram

    Measured: 12 weeks

Timeline

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

  1. First posted9 Jul 2024
  2. Study start25 Jul 2024
  3. Primary completion22 Apr 2025
  4. Study completion28 May 2025

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
probiotic vs placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491342
Sponsor's protocol ID
PMK GI 001
Status last verified
Jul 2025
First submitted
16 Jun 2024
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sasso M, Beaugrand M, de Ledinghen V, Douvin C, Marcellin P, Poupon R, Sandrin L, Miette V. Controlled attenuation parameter (CAP): a novel VCTE guided ultrasonic attenuation measurement for the evaluation of hepatic steatosis: preliminary study and validation in a cohort of patients with chronic liver disease from various causes. Ultrasound Med Biol. 2010 Nov;36(11):1825-35. doi: 10.1016/j.ultrasmedbio.2010.07.005. Epub 2010 Sep 27.

    PubMed 20870345

  • Dietrich CF, Bamber J, Berzigotti A, Bota S, Cantisani V, Castera L, Cosgrove D, Ferraioli G, Friedrich-Rust M, Gilja OH, Goertz RS, Karlas T, de Knegt R, de Ledinghen V, Piscaglia F, Procopet B, Saftoiu A, Sidhu PS, Sporea I, Thiele M. EFSUMB Guidelines and Recommendations on the Clinical Use of Liver Ultrasound Elastography, Update 2017 (Long Version). Ultraschall Med. 2017 Aug;38(4):e16-e47. doi: 10.1055/s-0043-103952. Epub 2017 Apr 13.

    PubMed 28407655

  • Shen QL, Chen YJ, Wang ZM, Zhang TC, Pang WB, Shu J, Peng CH. Assessment of liver fibrosis by Fibroscan as compared to liver biopsy in biliary atresia. World J Gastroenterol. 2015 Jun 14;21(22):6931-6. doi: 10.3748/wjg.v21.i22.6931.

    PubMed 26078570

  • Noureddin M, Lam J, Peterson MR, Middleton M, Hamilton G, Le TA, Bettencourt R, Changchien C, Brenner DA, Sirlin C, Loomba R. Utility of magnetic resonance imaging versus histology for quantifying changes in liver fat in nonalcoholic fatty liver disease trials. Hepatology. 2013 Dec;58(6):1930-40. doi: 10.1002/hep.26455. Epub 2013 Oct 17.

    PubMed 23696515

  • Middleton MS, Heba ER, Hooker CA, Bashir MR, Fowler KJ, Sandrasegaran K, Brunt EM, Kleiner DE, Doo E, Van Natta ML, Lavine JE, Neuschwander-Tetri BA, Sanyal A, Loomba R, Sirlin CB; NASH Clinical Research Network. Agreement Between Magnetic Resonance Imaging Proton Density Fat Fraction Measurements and Pathologist-Assigned Steatosis Grades of Liver Biopsies From Adults With Nonalcoholic Steatohepatitis. Gastroenterology. 2017 Sep;153(3):753-761. doi: 10.1053/j.gastro.2017.06.005. Epub 2017 Jun 15.

    PubMed 28624576

  • Sullivan A, Nord CE. Probiotic lactobacilli and bacteraemia in Stockholm. Scand J Infect Dis. 2006;38(5):327-31. doi: 10.1080/00365540500449826.

    PubMed 16709533

  • Sanyal AJ, Brunt EM, Kleiner DE, Kowdley KV, Chalasani N, Lavine JE, Ratziu V, McCullough A. Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology. 2011 Jul;54(1):344-53. doi: 10.1002/hep.24376.

    PubMed 21520200

  • Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

    PubMed 26707365

  • Chang Y, Jung HS, Cho J, Zhang Y, Yun KE, Lazo M, Pastor-Barriuso R, Ahn J, Kim CW, Rampal S, Cainzos-Achirica M, Zhao D, Chung EC, Shin H, Guallar E, Ryu S. Metabolically Healthy Obesity and the Development of Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2016 Aug;111(8):1133-40. doi: 10.1038/ajg.2016.178. Epub 2016 May 17.

    PubMed 27185080

  • Schnabl B, Brenner DA. Interactions between the intestinal microbiome and liver diseases. Gastroenterology. 2014 May;146(6):1513-24. doi: 10.1053/j.gastro.2014.01.020. Epub 2014 Jan 15.

    PubMed 24440671

  • Trinchieri G, Sher A. Cooperation of Toll-like receptor signals in innate immune defence. Nat Rev Immunol. 2007 Mar;7(3):179-90. doi: 10.1038/nri2038.

    PubMed 17318230

  • Imajo K, Fujita K, Yoneda M, Nozaki Y, Ogawa Y, Shinohara Y, Kato S, Mawatari H, Shibata W, Kitani H, Ikejima K, Kirikoshi H, Nakajima N, Saito S, Maeyama S, Watanabe S, Wada K, Nakajima A. Hyperresponsivity to low-dose endotoxin during progression to nonalcoholic steatohepatitis is regulated by leptin-mediated signaling. Cell Metab. 2012 Jul 3;16(1):44-54. doi: 10.1016/j.cmet.2012.05.012.

    PubMed 22768838

  • Wang S, Charbonnier LM, Noval Rivas M, Georgiev P, Li N, Gerber G, Bry L, Chatila TA. MyD88 Adaptor-Dependent Microbial Sensing by Regulatory T Cells Promotes Mucosal Tolerance and Enforces Commensalism. Immunity. 2015 Aug 18;43(2):289-303. doi: 10.1016/j.immuni.2015.06.014. Epub 2015 Jul 28.

    PubMed 26231118

  • Cani PD, Possemiers S, Van de Wiele T, Guiot Y, Everard A, Rottier O, Geurts L, Naslain D, Neyrinck A, Lambert DM, Muccioli GG, Delzenne NM. Changes in gut microbiota control inflammation in obese mice through a mechanism involving GLP-2-driven improvement of gut permeability. Gut. 2009 Aug;58(8):1091-103. doi: 10.1136/gut.2008.165886. Epub 2009 Feb 24.

    PubMed 19240062

  • Zhu L, Baker SS, Gill C, Liu W, Alkhouri R, Baker RD, Gill SR. Characterization of gut microbiomes in nonalcoholic steatohepatitis (NASH) patients: a connection between endogenous alcohol and NASH. Hepatology. 2013 Feb;57(2):601-9. doi: 10.1002/hep.26093. Epub 2013 Jan 8.

    PubMed 23055155

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Fatty Liver, Nonalcoholic, run by Phramongkutklao College of Medicine and Hospital at 2 sites in Thailand.

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 0 inclusion and 17 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. 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?

Liver steatosis by fibroscan (time frame: 12 weeks). The study lists 3 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 NCT06491342, which also lists 31 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 25 Jul 2025.

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