治験レーダーAI | ||
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治験 NCT07488975 (MASLD)（対象：代謝機能障害関連脂肪肝疾患）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation 第I相・フェーズ1 40 食事療法
Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials
- MASLD
- LL-IRB-2403
MASH
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Pasteurized 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 |
実験的Pasteurized 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 |
実験的Pasteurized 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 |
プラセボ対照薬Placebo 400 mg/capsule/day. Duration: 120 days | プラセボ 400 mg/capsule/day. Duration: 120 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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.