含低甲氧基果胶的肠内营养用于重症监护中的肠道耐受性（LOME-PECT）：一项随机对照试验的研究方案
Low-methoxy pectin-containing enteral nutrition in critical care for intestinal tolerance (LOME-PECT): Study protocol for a randomized controlled trial.
作者信息
Kashiwagi Shizuka, Takaki Shunsuke, Oi Yasufumi, Honzawa Hiroshi, Yamamoto Ryo, Yamashita Ikutaro, Ohki Izumi, Fujitani Shigeki, Nagatomi Akiyoshi, Ohshima Yuki, Yoshida Minoru, Yoshida Hideki, Kurisu Miyuki, Takahashi Yuji, Hashimoto Hideki, Koyama Yasuaki, Hatakeyama Junji, Shinoda Satoru, Yokoyama Nobuyuki, Nakamura Kensuke
机构信息
Department of Critical Care Medicine, Yokohama City University Medical Center, Yokohama, Japan.
Department of Anesthesiology and Critical Care Medicine, Yokohama City University School of Medicine, Yokohama, Japan.
出版信息
PLoS One. 2025 Jul 11;20(7):e0326582. doi: 10.1371/journal.pone.0326582. eCollection 2025.
BACKGROUND
Enteral nutrition is preferable over parenteral nutrition for critically ill patients, but is often discontinued due to enteral feeding intolerance. Diarrhea is one of the most common causes of the discontinuation of enteral nutrition and may be attributed to the composition of enteral formulas. Dietary fiber attenuates diarrhea by normalizing the intestinal microbiota, providing energy for colonic epithelial cells, and exerting a thickening effect on intestinal contents. We herein conducted a randomized controlled trial (RCT) to test the hypothesis that the administration of an enteral formula containing low-methoxy pectin, a type of dietary fiber, more effectively ameliorates diarrhea in critically ill adult patients than a similar composition without pectin.
METHODS
A protocol for planning a multicenter, parallel-group, open-label RCT is described herein. Enrolled patients are those ≥18 years of age with the indication of enteral nutrition by gastric access. Overall, 200 patients will be randomized into an intervention group administered an enteral formula containing low-methoxy pectin and a control group administered an enteral formula with similar components, but without pectin at a ratio of 1:1. Each enteral formula will be administered for 3 days or longer. There are no restrictions on other treatments. The primary outcome is the incidence of diarrhea as defined by Bristol Scale 5, 6, or 7. Secondary outcomes include the rate of EN failure, the survival rate, the lengths of ICU and hospital stays, and nutritional endpoints.
DISCUSSION
The present study examines the effects of a low-methoxy pectin-containing enteral formula on enteral feeding intolerance, including diarrhea, in critically ill patients. The results obtained may provide new considerations regarding the selection of enteral formulas for critically ill patients.
TRIAL REGISTRATION
jRCTs031230684 registered on 08 Mar 2024, https://jrct.niph.go.jp/en-latest-detail/jRCTs031230684.
背景
对于危重症患者，肠内营养优于肠外营养，但常因肠内喂养不耐受而中断。腹泻是肠内营养中断最常见的原因之一，可能归因于肠内营养配方的成分。膳食纤维通过使肠道微生物群正常化、为结肠上皮细胞提供能量以及对肠内容物发挥增稠作用来减轻腹泻。我们在此进行了一项随机对照试验（RCT），以检验以下假设：与不含果胶的类似配方相比，给予含有低甲氧基果胶（一种膳食纤维）的肠内营养配方能更有效地改善成年危重症患者的腹泻。
方法
本文描述了一项多中心、平行组、开放标签RCT的规划方案。纳入的患者为年龄≥18岁且有经胃途径进行肠内营养指征的患者。总体而言，200名患者将按1:1的比例随机分为干预组（给予含有低甲氧基果胶的肠内营养配方）和对照组（给予成分相似但不含果胶的肠内营养配方）。每种肠内营养配方将给予3天或更长时间。对其他治疗无限制。主要结局是布里斯托量表5、6或7所定义的腹泻发生率。次要结局包括肠内营养失败率、生存率、重症监护病房（ICU）住院时间和住院时间以及营养终点。
讨论
本研究探讨了含低甲氧基果胶的肠内营养配方对危重症患者肠内喂养不耐受（包括腹泻）的影响。所获得的结果可能为危重症患者肠内营养配方的选择提供新的思考。
试验注册
于2024年3月8日注册，注册号为jRCTs031230684，https://jrct.niph.go.jp/en-latest-detail/jRCTs031230684 。
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