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治験 NCT07342205（対象：急性呼吸窮迫症候群 (ARDS)、Acute Lung Injury(ALI)、Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome）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。 | ||
フィルター基準に一致する試験が1件見つかりました
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A Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation 第II相・フェーズ2, 第III相・フェーズ3 60
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治験番号 NCT07342205 は 急性呼吸窮迫症候群 (ARDS)、Acute Lung Injury(ALI)、Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome に関する 治療 の研究で、第II相・フェーズ2 第III相・フェーズ3 介入研究 臨床試験 です。現在は 募集中 で、2025年12月10日 から開始しています。60 名の参加者 の募集が計画されています。この試験は Shanghai University of Traditional Chinese Medicine によって主導され、2027年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月15日 です。
概要
Sepsis is a systemic inflammatory response syndrome triggered by infection, and it is a common critical illness in clinical practice, often leading to multiple organ dysfunction. Among these, acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are among the most severe complications. The mortality rate of sepsis-related lung injury is extremely high, reaching 30% - 50%. The existing treatment metho...もっと見る
詳細説明
Although certain research progress has been made in the pathogenesis and treatment of sepsis-related lung injury, many unresolved issues still exist. The existing treatment methods are unable to effectively reduce the high mortality rate of sepsis-related lung injury, and there are no specific treatment measures targeting the lung injury itself. Dysbiosis of the intestinal flora plays an important role in the occurre...もっと見る
公式タイトル
A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation
疾患名
急性呼吸窮迫症候群 (ARDS)Acute Lung Injury(ALI)Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndromeその他の研究識別子
- PTEC-R-2025-44-1
NCT番号
開始日
2025-12-10
最終更新日
2026-01-15
終了予定日
2027-06
目標参加者数
60
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
第III相・フェーズ3
第III相・フェーズ3
状況
募集中
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
プラセボ対照薬Evaluation of the clinical efficacy and mechanism of action of fecal microbiota transplantation (FMT The participants in this study will be divided into Group A and Group B. The participants in Group A will receive basic treatment and a placebo (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-DZ) for treatment. | Placebo control group The participants in Group A will receive basic treatment and placebo (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-DZ) for treatment. |
実験的Human-derived active intestinal bacterial liquid The participants in Group B will receive basic treatment and human-derived active intestinal flora liquid (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-GT122) for treatment. Two groups were infused with the corresponding bacterial solution and the placebo bacterial solution through the nasal tube. | Human-derived active intestinal bacterial liquid group The participants in Group B will receive basic treatment and human-derived active intestinal flora liquid (provided by Shanghai Baoteng Medical Laboratory, specification: 50 mL per bottle, serial number: 250713-GT122) for treatment. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Efficacy evaluation | Oxygenation index (PaO2/FiO2), | 0-28 days |
Efficacy evaluation | 28-day all-cause mortality rate | 0-28day |
Efficacy evaluation | ICU hospitalization time | 0-28day |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Inflammatory markers | The inflammatory biomarkers to be assessed include serum levels of C-reactive protein (CRP, measured in mg/L via immunoturbidimetric assay), | (Day0, 3, 7, 14) |
Vital signs (Day0 - 14) | Vital signs to be monitored as safety and physiological outcome measures | Day 0，3，7，14 |
Changes in intestinal flora | Changes in gut microbiota will be assessed as a secondary outcome by performing 16S ribosomal RNA gene sequencing on stool samples collected at baseline (pre-treatment), | Day0, 7, 28 |
Incidence of multi-drug resistant bacteria | The primary/secondary outcome measure is the incidence of multidrug-resistant organism (MDRO) infection, defined as the proportion of patients who develop a new infection with bacteria resistant to at least one agent in three or more antimicrobial categories, confirmed by standard microbiological culture and antibiotic susceptibility testing. | Day0, 7, 28 |
Oxidative stress indicators | Oxidative stress biomarkers to be measured. | Day0, 3, 7, 14 |
Functions of major organs | Myocardial enzyme profile outcome measures. | Day0, 3, 7, 14 |
SOFA score | SOFA Score Calculation | Day0, 3, 7, 14 |
Inflammatory markers | procalcitonin (PCT, measured in ng/mL via chemiluminescent immunoassay), | (Day0, 3, 7, 14) |
Inflammatory markers | tumor necrosis factor-alpha (TNF-α, measured in pg/mL via enzyme-linked immunosorbent assay). | (Day0, 3, 7, 14) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Age ≥ 18 years;
- Clear or suspected infection + SOFA score ≥ 2 points, and PaO₂/FiO₂ ≤ 300 mmHg;
- Capable of taking in nutrients (able to eat independently or receive enteral nutrition);
- Voluntarily participate in this trial and sign the informed consent form.
- Indications for exclusion from FMT (Fecal Microbiota Transplantation) include massive gastrointestinal bleeding, intestinal obstruction, organic intestinal disorders, and severe damage to intestinal mucosa;
- Individuals with severe immune deficiencies, such as those with AIDS, leukemia, and those using immunosuppressive drugs;
- Pregnant women and lactating women;
- Those who cannot undergo nasal-intestinal catheterization or other transplantation methods;
- Patients who cannot cooperate to complete the study; Other situations where the researchers determine that a patient is not suitable for participating in the clinical trial.
Shanghai University of Traditional Chinese Medicine責任者
Sun Yuting, 主任研究者, Dr, Shanghai University of Traditional Chinese Medicine
連絡先情報がありません。
1 1カ国の場所
Putuo
Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, Putuo, 421000, China
sun yuting Dr, 連絡先, 19821758594, [email protected]
募集中