- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07709611
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
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Sheng Wang
- 전화번호: +8613641715292
- 이메일: wangsheng@tongji.edu.cn
연구 장소
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Shanghai, 중국
- Shanghai Tongji Hospital
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연락하다:
- Huihui Zhu
- 전화번호: +8615821646026
- 이메일: huihui01727@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Branched-chain amino acid concentration
기간: Week 1
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Week 1
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Citrulline concentration
기간: Week 1
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Week 1
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Urine 3-methylhistidine concentration
기간: Week 1
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Week 1
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2차 결과 측정
결과 측정 |
기간 |
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Fecal elastase-1
기간: Week 1
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Week 1
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Serum pancreatic lipase levels
기간: Week 1
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Week 1
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Serum pancreatic amylase levels
기간: Week 1
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Week 1
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Plasma diamine oxidase levels
기간: Week 1
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Week 1
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Plasma D-lactate level
기간: Week 1
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Week 1
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P-cresol content in feces
기간: Week 1
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Week 1
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Indole content in feces
기간: 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
기간: Week 2
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Week 2
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28-day all-cause mortality
기간: Week 4
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Week 4
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-047
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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