ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07488975 (MASLD) के लिए चयापचय विकार-संबंधित स्टेटोटिक यकृत रोग वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation चरण I 40 आहार
Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials
- MASLD
- LL-IRB-2403
MASH
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकPasteurized 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 |
प्रयोगात्मकPasteurized 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 |
प्रयोगात्मकPasteurized 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 |
प्लेसबो तुलना समूहPlacebo 400 mg/capsule/day. Duration: 120 days | प्लेसबो 400 mg/capsule/day. Duration: 120 days |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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.