Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
NCT ID: NCT06585982
Last Updated: 2024-11-12
Study Results
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.
RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-04
2025-03-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Research question: Are there any changes in metabolic profile, Insulin and TNF-α and gut microbiota changes in MAFLD patients after synbiotic supplementation
Participants will:
* Treatment group given supplementation and the control group will be given placebo at a dose of 2x1 tablet for 12 weeks.
* Patients will visit the hospital every 28 days for up to 4 months for control and follow-up supplementation.
* patients will be given a supplement consumption compliance logbook and a food record logbook used to record food consumption filled in by the patient.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics
NCT00068094
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
NCT02124759
The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients
NCT04552002
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
NCT04642482
Type 2 Diabetes Intervention by Gut Microbiota-directed Diet -a Open Labelled RCT
NCT05541237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The pathogenesis mechanism of MAFLD is complex and involves several factors such as mitochondrial dysfunction, oxidative stress, and increased free fatty acids (FFA). The 'multi-hit' theory explains how lifestyle, environmental and genetic factors contribute to the development of MAFLD. The gut microbiota also plays an important role in the development of MAFLD through the gut-liver axis, where microbiota imbalance can lead to inflammation and liver damage.
Research shows the microbiota composition in MAFLD patients is different from healthy people, with an increase in Proteobacteria and Actinobacteria and a decrease in butyrate-producing bacteria. Interventions with probiotics and prebiotics (synbiotics) have been shown to reduce liver fibrosis and improve metabolic profiles. The investigators are interested in assessing the effects of synbiotics on changes in metabolic biomarkers, insulin, TNF-α, and gut microbiota in MAFLD patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RILLUS
Treatment group receive RILLUS, a synbiotic that each tablet contains Viable cells 1.0 x 109 CFU containing three types of prebiotic species (Lactobacillus plantarum 8.55mg, Streptococcus thermophilus 8.55mg, and Bifidobacterium bifidum 2.55 mg) and Fructooligosaccharide (FOS) 480 mg as prebiotic.
Treatment
RILLUS is a synbiotic produced by Kalbe Farma
Placebo
Control group receive what appeared to be RILLUS, but only placebo containing Fructooligosaccharide, Xylitol DC, Isomalt, Microcrystalline cellulose, Corn starch, Milk flavor powder, Hydroxypropyl methylcellulose, Vanilla flavor powder, Magnesium stearate
Control
Placebo produced by Kalbe Farma
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment
RILLUS is a synbiotic produced by Kalbe Farma
Control
Placebo produced by Kalbe Farma
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients are willing to become research respondents after filling out informed consent
3. Patients can and are willing to consume supplements orally within a predetermined time
4. Patients are willing to record compliance with taking supplements in a diary that has been provided
5. Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m
Exclusion Criteria
2. Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study.
3. Patients with a history of alcohol consumption \>40 g/day.
4. Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage
5. Patients with Hepatocellular Carcinoma (HCC)
6. Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD)
7. Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month
8. Use of Vitamin E and omega-3 fatty acids
9. Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
25 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Kariadi General Hospital Medical Center
OTHER
PT Kalbe Farma Tbk
INDUSTRY
Universitas Diponegoro
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adriyan Pramono
Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hery D Purnomo, Dr
Role: PRINCIPAL_INVESTIGATOR
Dr. Kariadi Medical Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RSUP Dr. Kariadi
Semarang, Semarang, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Meagratia, R. A., Cayami, F. K., Bahrudin, U., Lestari, W., Maharani, N., Faradz, S. M., & Purnomo, H. D. (2021). Adiponutrin and Adiponectin Gene Variants in Indonesian Patients with Non-Alcoholic Fatty Liver Disease: a Preliminary Study. In Journal of Biomedicine and Translational Research (Vol. 7, Issue 2, pp. 86-91). Institute of Research and Community Services Diponegoro University (LPPM UNDIP). https://doi.org/10.14710/jbtr.v7i2.11777
Verma N, Duseja A, Mehta M, De A, Lin H, Wong VW, Wong GL, Rajaram RB, Chan WK, Mahadeva S, Zheng MH, Liu WY, Treeprasertsuk S, Prasoppokakorn T, Kakizaki S, Seki Y, Kasama K, Charatcharoenwitthaya P, Sathirawich P, Kulkarni A, Purnomo HD, Kamani L, Lee YY, Wong MS, Tan EXX, Young DY. Machine learning improves the prediction of significant fibrosis in Asian patients with metabolic dysfunction-associated steatotic liver disease - The Gut and Obesity in Asia (GO-ASIA) Study. Aliment Pharmacol Ther. 2024 Mar;59(6):774-788. doi: 10.1111/apt.17891. Epub 2024 Feb 1.
The Relationship between the Duration of Suffering from Diabetes and HbA1c Levels with the Degree of Liver Stiffness in Type 2 Diabetes Mellitus Patients
Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.
Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.
Boccatonda A, Andreetto L, D'Ardes D, Cocco G, Rossi I, Vicari S, Schiavone C, Cipollone F, Guagnano MT. From NAFLD to MAFLD: Definition, Pathophysiological Basis and Cardiovascular Implications. Biomedicines. 2023 Mar 13;11(3):883. doi: 10.3390/biomedicines11030883.
Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
Mathews SE, Kumar RB, Shukla AP. Nonalcoholic steatohepatitis, obesity, and cardiac dysfunction. Curr Opin Endocrinol Diabetes Obes. 2018 Oct;25(5):315-320. doi: 10.1097/MED.0000000000000432.
Rachmatullah TF, Permatadewi CO, Hutami HT, Limantoro C, Purnomo, MD, PhD HD. Correlation between Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score (NFS) with Left Ventricular Mass Index (LVMI) in patients with NAFLD. J Biomed Transl Res. 2021 Aug 31;7(2):79-85.
Purnomo HD, Kasno, Sudijanto E, Hirlan, Darmono, Daldiyono, et al. The roles of metabolic syndrome and several biomarkers in incidence and severity of non-alcoholic fatty liver disease. Hiroshima J Med Sci. 2018;67(4):138-46.
Buzzetti E, Pinzani M, Tsochatzis EA. The multiple-hit pathogenesis of non-alcoholic fatty liver disease (NAFLD). Metabolism. 2016 Aug;65(8):1038-48. doi: 10.1016/j.metabol.2015.12.012. Epub 2016 Jan 4.
Tilg H, Adolph TE, Moschen AR. Multiple Parallel Hits Hypothesis in Nonalcoholic Fatty Liver Disease: Revisited After a Decade. Hepatology. 2021 Feb;73(2):833-842. doi: 10.1002/hep.31518. Epub 2021 Feb 6. No abstract available.
Boursier J, Diehl AM. Nonalcoholic Fatty Liver Disease and the Gut Microbiome. Clin Liver Dis. 2016 May;20(2):263-75. doi: 10.1016/j.cld.2015.10.012. Epub 2015 Dec 24.
Park E, Jeong JJ, Won SM, Sharma SP, Gebru YA, Ganesan R, Gupta H, Suk KT, Kim DJ. Gut Microbiota-Related Cellular and Molecular Mechanisms in the Progression of Nonalcoholic Fatty Liver Disease. Cells. 2021 Oct 2;10(10):2634. doi: 10.3390/cells10102634.
Zhang Y, Yan S, Sheng S, Qin Q, Chen J, Li W, Li T, Gao X, Wang L, Ang L, Ding S. Comparison of gut microbiota in male MAFLD patients with varying liver stiffness. Front Cell Infect Microbiol. 2022 Aug 3;12:873048. doi: 10.3389/fcimb.2022.873048. eCollection 2022.
Oh JH, Lee JH, Cho MS, Kim H, Chun J, Lee JH, Yoon Y, Kang W. Characterization of Gut Microbiome in Korean Patients with Metabolic Associated Fatty Liver Disease. Nutrients. 2021 Mar 21;13(3):1013. doi: 10.3390/nu13031013.
Behrouz V, Aryaeian N, Zahedi MJ, Jazayeri S. Effects of probiotic and prebiotic supplementation on metabolic parameters, liver aminotransferases, and systemic inflammation in nonalcoholic fatty liver disease: A randomized clinical trial. J Food Sci. 2020 Oct;85(10):3611-3617. doi: 10.1111/1750-3841.15367. Epub 2020 Sep 4.
Bomhof MR, Parnell JA, Ramay HR, Crotty P, Rioux KP, Probert CS, Jayakumar S, Raman M, Reimer RA. Histological improvement of non-alcoholic steatohepatitis with a prebiotic: a pilot clinical trial. Eur J Nutr. 2019 Jun;58(4):1735-1745. doi: 10.1007/s00394-018-1721-2. Epub 2018 May 19.
Mofidi F, Poustchi H, Yari Z, Nourinayyer B, Merat S, Sharafkhah M, Malekzadeh R, Hekmatdoost A. Synbiotic supplementation in lean patients with non-alcoholic fatty liver disease: a pilot, randomised, double-blind, placebo-controlled, clinical trial. Br J Nutr. 2017 Mar;117(5):662-668. doi: 10.1017/S0007114517000204. Epub 2017 Mar 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CT-1583
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.