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

NCT ID: NCT06491342

Last Updated: 2025-07-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-25

Study Completion Date

2025-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatty Liver, Nonalcoholic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

probiotic vs placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Maltodextrin in bovine gelatin capsule look same as probiotic (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

probiotic

Lactobacillus 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)

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Probiotic-Lactobacillus Zeae and Lactobacillus reuteri

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic

Probiotic-Lactobacillus Zeae and Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD

Exclusion Criteria

1. Supplement with probiotic/prebiotic within 2 weeks
2. Previous antibiotic/antifungus within 1 month
3. 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
4. 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
5. Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
6. Hepatic decompensation or impairment defined as presence of any of the following:

* History of esophageal varices, ascites or hepatic encephalopathy.
* Serum albumin \<3.5 g dl-1, except as explained by nonhepatic causes.
* INR \> 1.4
7. Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
8. Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
9. Active malignancy on treatment
10. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \<30%
11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
12. Respiratory compromised
13. Severe renal impairment (eGFR \<30 ml/min/1.73 m2)
14. Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chiang Mai University

OTHER

Sponsor Role collaborator

Thailand Institute of scientific and technological research

UNKNOWN

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Natchaporn Noppacroh

Role: PRINCIPAL_INVESTIGATOR

phramongkutklao

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of gastroenterology and hepatology

Ratchathewi, Bangkok, Thailand

Site Status

Chiangmai university

Chiang Mai, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21520200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26707365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27185080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24440671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17318230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22768838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26231118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19240062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23055155 (View on PubMed)

Bron PA, Kleerebezem M, Brummer RJ, Cani PD, Mercenier A, MacDonald TT, Garcia-Rodenas CL, Wells JM. Can probiotics modulate human disease by impacting intestinal barrier function? Br J Nutr. 2017 Jan;117(1):93-107. doi: 10.1017/S0007114516004037.

Reference Type BACKGROUND
PMID: 28102115 (View on PubMed)

Alisi A, Bedogni G, Baviera G, Giorgio V, Porro E, Paris C, Giammaria P, Reali L, Anania F, Nobili V. Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2014 Jun;39(11):1276-85. doi: 10.1111/apt.12758. Epub 2014 Apr 16.

Reference Type BACKGROUND
PMID: 24738701 (View on PubMed)

Abhari K, Saadati S, Yari Z, Hosseini H, Hedayati M, Abhari S, Alavian SM, Hekmatdoost A. The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial. Clin Nutr ESPEN. 2020 Oct;39:53-60. doi: 10.1016/j.clnesp.2020.06.020. Epub 2020 Jul 24.

Reference Type BACKGROUND
PMID: 32859329 (View on PubMed)

Ferolla SM, Couto CA, Costa-Silva L, Armiliato GN, Pereira CA, Martins FS, Ferrari Mde L, Vilela EG, Torres HO, Cunha AS, Ferrari TC. Beneficial Effect of Synbiotic Supplementation on Hepatic Steatosis and Anthropometric Parameters, But Not on Gut Permeability in a Population with Nonalcoholic Steatohepatitis. Nutrients. 2016 Jun 28;8(7):397. doi: 10.3390/nu8070397.

Reference Type BACKGROUND
PMID: 27367724 (View on PubMed)

Zhou D, Fan JG. Microbial metabolites in non-alcoholic fatty liver disease. World J Gastroenterol. 2019 May 7;25(17):2019-2028. doi: 10.3748/wjg.v25.i17.2019.

Reference Type BACKGROUND
PMID: 31114130 (View on PubMed)

Rau M, Rehman A, Dittrich M, Groen AK, Hermanns HM, Seyfried F, Beyersdorf N, Dandekar T, Rosenstiel P, Geier A. Fecal SCFAs and SCFA-producing bacteria in gut microbiome of human NAFLD as a putative link to systemic T-cell activation and advanced disease. United European Gastroenterol J. 2018 Dec;6(10):1496-1507. doi: 10.1177/2050640618804444. Epub 2018 Sep 30.

Reference Type BACKGROUND
PMID: 30574320 (View on PubMed)

Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.

Reference Type BACKGROUND
PMID: 16157765 (View on PubMed)

Carr RM, Oranu A, Khungar V. Nonalcoholic Fatty Liver Disease: Pathophysiology and Management. Gastroenterol Clin North Am. 2016 Dec;45(4):639-652. doi: 10.1016/j.gtc.2016.07.003. Epub 2016 Oct 13.

Reference Type BACKGROUND
PMID: 27837778 (View on PubMed)

Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18.

Reference Type BACKGROUND
PMID: 30660725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20870345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28407655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26078570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23696515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28624576 (View on PubMed)

Ahn SB, Jun DW, Kang BK, Lim JH, Lim S, Chung MJ. Randomized, Double-blind, Placebo-controlled Study of a Multispecies Probiotic Mixture in Nonalcoholic Fatty Liver Disease. Sci Rep. 2019 Apr 5;9(1):5688. doi: 10.1038/s41598-019-42059-3.

Reference Type BACKGROUND
PMID: 30952918 (View on PubMed)

Doron S, Snydman DR. Risk and safety of probiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S129-34. doi: 10.1093/cid/civ085.

Reference Type BACKGROUND
PMID: 25922398 (View on PubMed)

Snydman DR. The safety of probiotics. Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S104-11; discussion S144-51. doi: 10.1086/523331.

Reference Type BACKGROUND
PMID: 18181712 (View on PubMed)

Salminen MK, Rautelin H, Tynkkynen S, Poussa T, Saxelin M, Valtonen V, Jarvinen A. Lactobacillus bacteremia, clinical significance, and patient outcome, with special focus on probiotic L. rhamnosus GG. Clin Infect Dis. 2004 Jan 1;38(1):62-9. doi: 10.1086/380455. Epub 2003 Dec 4.

Reference Type BACKGROUND
PMID: 14679449 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16709533 (View on PubMed)

Zielinska D, Sionek B, Kołozyn-Krajewska D. Safety of Probiotics. Diet, Microbiome and Health. 2018;:131-161

Reference Type BACKGROUND

Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10.

Reference Type BACKGROUND
PMID: 25500202 (View on PubMed)

Zhou D, Pan Q, Liu XL, Yang RX, Chen YW, Liu C, Fan JG. Clostridium butyricum B1 alleviates high-fat diet-induced steatohepatitis in mice via enterohepatic immunoregulation. J Gastroenterol Hepatol. 2017 Sep;32(9):1640-1648. doi: 10.1111/jgh.13742.

Reference Type BACKGROUND
PMID: 28109017 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMK GI 001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.