Investigating a probiotic treatment for fatty liver disease

Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials

This study is testing whether a specific probiotic can help people with fatty liver disease improve their health compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06873165 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a pasteurized strain of Akkermansia muciniphila in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Participants will take either the probiotic or a placebo daily for three months, with regular clinic visits for monitoring. The study will assess changes in body weight, blood lipid levels, and other metabolic markers to determine the treatment's effectiveness compared to the placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 70 diagnosed with MASLD and exhibiting specific metabolic dysfunction criteria.

Not a fit: Patients with severe liver disease or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from MASLD.

How similar studies have performed: Previous studies have indicated the potential of gut microbiota modulation in treating liver diseases, suggesting a promising avenue for this approach.

Eligibility criteria

Inclusion Criteria:

* Male or female subjects aged between 20 and 70 years old.
* The subject is diagnosed through FibroScan (CAP≧ 260 db/m)and meets one of below .
* the subject's BMI ≧23 kg/m² or waist ≧ 90cm (male) 80cm (Female)
* Fasting glucose≧100 mg/dL or sugar after meal ≧140 mg/dL or HbA1c≧5.7 or diagnosed type II diabetes(including under treatment or not)
* Blood pressure≧ 130/80 mmHg or under medication.
* Blood Triglycerides≧150 mg/dL or under medication.
* Blood HDL ≤ 40 mg/dL (Male) ≤ 50 mg/dL (Female) or under medication.
* If the subject is reproductive women, she should agree to take more than two ways of contraceptive methods.
* The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
* The subject agrees to comply with the following two requirements:

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:

* The subject is pregnant or lactating.
* The subject has received probiotics or prebiotics 14 days prior to visit 1.
* The subject has received any antibiotic (excluding topical agents) or antifungals within 30 days prior to visit 1.
* The subject has received medication affecting evaluating indicators 14 days prior to visit 1, including steroids, immunosuppressant or anti-inflammation drugs hepatitis and lipid, metabolism related compounds, but excluding the following medicines: Statins, Fibrates, Silymarin, Thiazolidinediones, Metformin, Fibrate, Cholestyramine, Ezetimibe, Orlistat, SGLT2i and GLP1-RAs.

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.

* The subject has a clinically significant, currently active or underlying diarrhea (loose stools more than three times in 24 hours) of infectious etiologies.
* The subject who has been diagnosed a severe/injury hepatic disease, disease affecting liver function, active inflammatory bowel disease.
* Acute hepatitis caused by viruses or other causes and ALT \> 200 U/L.
* Coronary artery disease with arterial stent surgery in half year.
* Fasting glucose≥ 300 mg/dl or HbA1c\>9%.
* Blood triglyceride≥ 500 mg/dl.
* The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetic within 30 days prior to visit 1.
* The subject has participated in body weight control plan within 60 days prior to visit 1.
* The subject has been aboard for 10 days within 60 days prior to visit 1, or plans to go aboard during this study.
* The subject is special diet.
* The subject is considered by the investigator as not suitable for the trial.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Ming-Shiang Wu, M.D., Ph.D.

Conditions Metabolic Dysfunction-Associated Steatotic Liver Disease; Akkermansia muciniphila