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The goal of this clinical trial is to investigate the efficacy and safety of pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Patients. The main question it aims to answer is:
Does pAKK NTUH_Amuc03 trend to reduce the body weight, improve abnormal blood lipids , NASLD activity score, and HOMA-IR ?
Researchers will compare pAKK NTUH_Amuc03 to a placebo (a look-alike substance that contains no Akk) to see if pAKK NTUH_Amuc03 works to MASLD.
Participants will:
Full description
Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)is an improved diagnostic standard derived from Non-Alcoholic Fatty Liver Disease (NAFLD), emphasizing the correlation between fatty liver and metabolic dysfunction. Compared to NAFLD, which requires the exclusion of various conditions for diagnosis, the diagnostic criteria for MASLD can enhance the homogeneity of study subjects. It also addresses various groups with coexisting liver diseases, aiding in the efficiency and applicability of new drug development. MASLD has a prevalence rate of approximately one-fourth of the global population. If left untreated and worsens, it may lead to liver fibrosis, cirrhosis, or even liver cancer. Due to the significant medical burden associated with MASLD and the lack of FDA-approved treatments, the development of therapeutic methods for MASLD is an urgent issue. Past literature indicates that diet and gut microbiota play crucial roles in the progression of MASLD. The composition of the diet affects gut microbiota and intestinal barrier function. In cases of dysbiosis, harmful substances produced by gut microbiota, including pathogen-associated molecular patterns (PAMPs) and microbiota-dependent metabolites (MDMs), enter the liver through the portal vein via the leaky gut, resulting in toxicity. The pathogenic pathways exacerbating MASLD through gut microbiota dysbiosis, collectively termed the gut-liver axis, are not fully understood. Some animal studies have found dietary supplements to regulate gut microbiota beneficial for improving MASLD. Although most lack clinical evidence, incorporating food components that regulate gut microbiota and immune function into the diet indeed holds potential for treating MASLD. Next-generation probiotics have been found in past studies to improve liver lipid metabolism and regulate gut microbiota. They may slow the progression of MASLD by modulating the gut-liver axis. Previous studies by our team applied the pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03), in preclinical animal studies to alleviate fatty liver disease progression. In experiments with mice induced with high-fat, high-fructose, high-cholesterol diets, pAKK NTUH_Amuc03 trended to reduce the body weight, improve abnormal blood lipids in mice, NASLD activity score, and HOMA-IR. These results indicate the potential of pAKK NTUH_Amuc03 to slow the progression of MASLD. Therefore, this project aims to further evaluate the efficacy and safety of pAKK NTUH_Amuc03 in MASLD patients through clinical trials.
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Inclusion criteria
comply with all follow-up visit requirements according to the trial protocol. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.
Exclusion criteria
If the above-mentioned drugs are used continuously for more than six months and the dosage is not changed during the trial,this situation is accepted.
Primary purpose
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Interventional model
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40 participants in 4 patient groups, including a placebo group
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Central trial contact
Ming-Shiang Wu, M.D., Ph.D.
Data sourced from clinicaltrials.gov
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