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

NCT06873165 | Recruiting

• 1 other identifier: 202403035RSC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Take capsule with pAKK NTUH\_Amuc03 or a placebo every day for 3 months
2. 2.Visit the clinic once every 4 weeks for checkups and tests

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Metabolic Dysfunction-Associated Steatotic Liver Disease; Akkermansia muciniphila

Outcome Measures

Primary Outcomes (2)

• Changes in gut microbiota

  evaluated by fecal 16S rRNA gene sequencin

  baseline and after 12-13th weeks

• Improvement of intrahepatic fibrosis

  evaluated by FibroScan

  baseline 、 12th and 16th weeks

Secondary Outcomes (2)

• Changes in FIB-4

  baseline 、 12th and 16th weeks

• Changes in gut permeability

  baseline to 12th week

Study Arms (4)

Placebo

PLACEBO COMPARATOR

1 capsule per day for 12 weeks

Dietary Supplement: Placebo

Active Comparator: AKK-1

ACTIVE COMPARATOR

1 capsule (with 1000000000 CFU pAKK LWHK0003) per day for 12 weeks

Dietary Supplement: Probiotics

Active Comparator: AKK-2

ACTIVE COMPARATOR

1 capsule (with 10000000000 CFU pAKK LWHK0003) per day for 12 weeks

Dietary Supplement: Probiotics

Active Comparator: AKK-3

ACTIVE COMPARATOR

1 capsule (with 100000000000 CFU pAKK LWHK0003) per day for 12 weeks

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

1 capsule(with three different dosage) per day for 12 weeks

Also known as: Akkermansia muciniphila

Active Comparator: AKK-1; Active Comparator: AKK-2; Active Comparator: AKK-3

Placebo DIETARY_SUPPLEMENT

1 capsule per day for 12weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Related Links

• The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world health
• Metabolic risk factors are associated with non-hepatitis B non-hepatitis C hepatocellular carcinoma in Taiwan, an endemic area of chronic hepatitis B
• Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Ming-Shiang Wu, M.D., Ph.D.

CONTACT

02-2312-3456; mingshiang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: January 22, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-01

Locations

TW (1)