Investigating a probiotic treatment for fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Ming-Shiang Wu, M.D., Ph.D.
• Email: mingshiang@ntu.edu.tw
• Phone: 02-2312-3456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Health profile of MASLD in Kazakhstan and real-world use of Ursosan in Almaty

  This study tests how MASLD appears in adults in Kazakhstan and how Ursosan is used in real-world care for a subgroup in Almaty.

  Recruiting at 7 sites Kazakh Association of Internal Medicine Specialists · Aktobe, Aktobe and 6 other locations · NCT07889999

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

  Recruiting University Hospital Muenster · Münster · NCT07877272

• ALN-CIDEB in adults with MASLD to see if it helps the liver

  This study tests whether ALN-CIDEB can help adults with MASLD and its liver damage compared to placebo.

  Recruiting at 4 sites Phase 3 Regeneron Pharmaceuticals · Miami, Florida and 3 other locations · NCT07854782

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Taiwan green propolis for MASLD and lipid/metabolic issues

  This study tests whether Taiwan green propolis capsules can improve blood lipids and body fat in adults with MASLD compared to a placebo over 12 weeks.

  Recruiting Taipei Medical University · Dalin · NCT07692438

• Secukinumab retention in adults with plaque psoriasis and MASLD in Spain

  This study tests how long people with plaque psoriasis and MASLD stay on secukinumab in real-world Spain, using EMR data from several hospitals.

  Recruiting at 9 sites Novartis · Badalona, Barcelona and 8 other locations · NCT07683065

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.