A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
Comparison of Protein Absorption Efficiency Between Peptide and Whole Protein Enteral Nutrition Preparations in High-risk Groups With Pancreatic Exocrine Insufficiency in the ICU
The goal of this clinical trial is to systematically evaluate whether peptide-type enteral nutrition (EN) formulations improve protein uptake efficiency in high-risk groups at ICU PEI, using targeted amino acid metabolomics and gut microbiota co-metabolomics as core quantitative indicators.
Researchers will compare protein absorption efficiency of short-chain peptide and complete protein enteral nutrition formulas in high-risk populations for PEI in the ICU
Participants will:
Enteral nutrition was administered for ICU critically ill patients with high-risk factors for PEI
調査の概要
状態
介入・治療
詳細な説明
The study subjects that meet the inclusion criteria will be randomly assigned in a 1:1 ratio to the peptide group and the whole protein group according to the following allocation scheme:
- Peptide Group: Receives nutritional support therapy with a peptide-based enteral nutrition (EN) formulation. The selected formulation must contain 5 g of protein per 100 ml and be composed entirely of hydrolyzed whey protein, which can be absorbed by the intestine without the need for thorough digestion by pancreatic enzymes.
- Whole Protein Group: Receives nutritional support therapy with a whole protein-based EN formulation. The selected formulation also contains 5 g of protein per 100 ml and consists of intact protein components, which require digestion and breakdown by pancreatic enzymes before being absorbed.
Both groups of study subjects will strictly follow the 2025 ASPEN Guidelines for Nutritional Therapy in Critically Ill Patients and the relevant expert consensus on critical care nutrition in China. Apart from the difference in the type of EN formulation, all other treatment measures (including anti-infection therapy, organ function support, gastrointestinal motility regulation, sedation and analgesia) will be carried out in accordance with standard ICU clinical practices to ensure consistency in the baseline treatment conditions between the two groups.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Sheng Wang
- 電話番号：+8613641715292
- メール：wangsheng@tongji.edu.cn
研究場所
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Shanghai、中国
- Shanghai Tongji Hospital
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コンタクト：
- Huihui Zhu
- 電話番号：+8615821646026
- メール：huihui01727@163.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age≥ 18 years old, no gender restriction;
- Meet the criteria for high-risk groups for PEI;
- AGI≤ Class II, hemodynamically stable, meeting EN initiation criteria;
- Estimated duration of enteral nutrition support therapy: ≥7 days;
- The subject or their legally authorized family member must sign the informed consent form
Exclusion Criteria:
- Patients who have been clearly diagnosed with PEI or chronic persistent PEI;
- Patients who have contraindications to enteral nutrition therapy;
- Patients with severely impaired liver or kidney function;
- Patients who suffer from amino acid metabolism disorders, severe malnutrition, or cachexia;
- Patients who have received pancreatic enzyme replacement therapy or taken any medications that may affect protein absorption within 7 days prior to enrollment;
- Patients for whom the expected length of ICU stay is less than 7 days;
- Pregnant or lactating women, as well as patients with mental illnesses;
- Patients who are allergic to any component of the study medication.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Short peptide group
Short peptide EN preparations were administered for nutritional support
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Short peptide EN preparations were administered for nutritional support
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アクティブコンパレータ：Protein group
Nutritional support therapy was administered with protein type EN preparations
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Nutritional support therapy was administered with protein-type EN preparations
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Branched-chain amino acid concentration
時間枠：Week 1
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Week 1
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Citrulline concentration
時間枠：Week 1
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Week 1
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Urine 3-methylhistidine concentration
時間枠：Week 1
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Week 1
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Fecal elastase-1
時間枠：Week 1
|
Week 1
|
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Serum pancreatic lipase levels
時間枠：Week 1
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Week 1
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Serum pancreatic amylase levels
時間枠：Week 1
|
Week 1
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Plasma diamine oxidase levels
時間枠：Week 1
|
Week 1
|
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Plasma D-lactate level
時間枠：Week 1
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Week 1
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P-cresol content in feces
時間枠：Week 1
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Week 1
|
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Indole content in feces
時間枠：Week 1
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Week 1
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Ultrasound is used to detect the thickness of the rectus femoris and assess the degree of muscle attenuation
時間枠：Week 2
|
Week 2
|
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28-day all-cause mortality
時間枠：Week 4
|
Week 4
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-047
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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