Evidence map›Paper›PMID 40644401›Full record

ArticlePloS one2025

Low-methoxy pectin-containing enteral nutrition in critical care for intestinal tolerance (LOME-PECT): Study protocol for a randomized controlled trial.

Shizuka Kashiwagi, Shunsuke Takaki, Yasufumi Oi, Hiroshi Honzawa, Ryo Yamamoto, Ikutaro Yamashita, Izumi Ohki, Shigeki Fujitani, Akiyoshi Nagatomi, Yuki Ohshima and 10 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Shizuka KashiwagiDepartment of Critical Care Medicine, Yokohama City University Medical Center, Yokohama, Japan.
Shunsuke TakakiDepartment of Anesthesiology and Critical Care Medicine, Yokohama City University School of Medicine, Yokohama, Japan.
Yasufumi OiDepartment of Emergency Medicine, Yokohama City University School of Medicine, Yokohama, Japan.
Hiroshi HonzawaDepartment of Emergency Medicine, Yokohama City University School of Medicine, Yokohama, Japan.
Ryo YamamotoDepartment of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan.
Ikutaro YamashitaDepartment of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan.
Izumi OhkiCatering and Nutrition Office, Keio University Hospital, Tokyo, Japan.
Shigeki FujitaniDepartment of Emergency and Critical Care Medicine, St.Marianna University School of Medicine, Kawasaki, Japan.
Akiyoshi NagatomiDepartment of Emergency and Critical Care Medicine, St.Marianna University School of Medicine, Kawasaki, Japan.
Yuki OhshimaDivision of Clinical Nutrition, St. Marianna University School of Medicine, Kawasaki, Japan.
Minoru YoshidaDepartment of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan.
Hideki YoshidaDepartment of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan.
Miyuki KurisuDepartment of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan.
Yuji TakahashiDepartment of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Japan.
Hideki HashimotoDepartment of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Japan.
Yasuaki KoyamaDepartment of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Japan.
Junji HatakeyamaDepartment of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Satoru ShinodaDepartment of Biostatistics, School of Medicine, Yokohama City University, Yokohama, Japan.
Nobuyuki YokoyamaDepartment of Anesthesiology and Critical Care Medicine, Yokohama City University School of Medicine, Yokohama, Japan.
Kensuke NakamuraDepartment of Anesthesiology and Critical Care Medicine, Yokohama City University School of Medicine, Yokohama, Japan.ORCID https://orcid.org/0000-0001-8481-0294

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnteral 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.

methodsA 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 registrationjRCTs031230684 registered on 08 Mar 2024, https://jrct.niph.go.jp/en-latest-detail/jRCTs031230684.

Indexed as

Critical CareDiarrheaEnteral NutritionPectinsAdultAgedCritical IllnessDietary FiberFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicDietary FiberPectins

Identifiers

PMID40644401
PMCPMC12250234

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.