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임상시험 NCT07488975 (MASLD)은(는) 대사 기능 장애 관련 지방간 질환에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation 1상 40 식이 요법
Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials
- MASLD
- LL-IRB-2403
MASH
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Pasteurized Akkermansia muciniphila LWHK0003 _low dose 400 mg/capsule/day. Duration: 120 days | Pasteurized Akkermansia Muciniphila LWHK0003 Low Dose 400 mg/capsule/days. Duration: 120 days |
실험적Pasteurized Akkermansia muciniphila LWHK0003 _medium dose 400 mg/capsule/day. Duration: 120 days | Pasteurized Akkermansia Muciniphila LWHK0003 Medium Dose 400 mg/capsule/day. Duration: 120 days |
실험적Pasteurized Akkermansia muciniphila LWHK0003 _high dose 400 mg/capsule/day. Duration: 120 days | Pasteurized Akkermansia Muciniphila LWHK0003 High Dose 400 mg/capsule/day. Duration: 120 days |
위약 대조군Placebo 400 mg/capsule/day. Duration: 120 days | 위약 400 mg/capsule/day. Duration: 120 days |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Liver steatosis, fibrosis, liver stiffness, and FIB-4 index | To assess the statistical differences between baseline and Weeks 12 and 16 (Visit V5 and V6) after administration of placebo or different doses (10⁹, 10¹⁰, 10¹¹ CFU) of pAKK LWHK0003 capsules, in terms of liver fat content (steatosis), fibrosis, liver stiffness, and FIB-4 index as measured by FibroScan and MRI/MRE. | From enrollment to the end of treatment, up to 52 weeks |
- Fibroscan，CAP ≧ 260db/m
C. Patients who have used antibiotics (except skin lotions) or antifungal drugs within 30 days before the screening visit.
D. Use of glucagon-like peptide-1 receptor agonists (GLP1-RAs) within six months prior to the screening visit.
E. Use of drugs that may affect the evaluation index within 14 days before the screening visit, during the screening visit, or during the planned trial period, such as steroids, immunosuppressants, or anti-inflammatory drugs, or drugs containing ingredients for treating hepatitis or affecting fat metabolism, including HMG-CoA reductase inhibitors (statins), fibrates, silymarin, thiazolidinediones, metformin, cholestyramine, ezetimibe, orlistat, and sodium-glucose transporter type 2 inhibitors (SGLT2i). This restriction does not apply if the above-mentioned drugs have been used continuously for more than six months and the dosage is not changed during the trial.
F. Those who have had severe gastrointestinal infection diarrhea symptoms within 14 days before the screening visit (more than three watery stools in 24 hours).
G. Have the following medical history or laboratory abnormalities:
Leeuwenhoek Laboratories Co. Ltd.