臨床研究等提出・公開システム

Low-Methoxy Pectin containing Enteral nutrition in Critically care for intestinal Tolerance (LOME-PECT trial)

LOME-PECT trial (LOME-PECT trial)

199

There were no obvious differences between the two groups in terms of age, sex, BMI, underlying diseases, SOFA score, MUST score, or blood test results (no statistical tests were performed).

A total of 203 patients were enrolled and randomized, resulting in 101 patients were allocated to the study treatment group and 102 patients to the control treatment group. The study treatment group (n=97) and control treatment group (n=99) who had a primary outcome assessment were analyzed as per the Full Analysis Set (FAS). The study treatment group (n=98) and control treatment group (n=101) who completed the protocol were analyzed as per the Safety Analysis Set (SAS).

In the SAS trial treatment group (98 patients) and the control treatment group (101 patients), no serious adverse events considered causally related to the treatment occurred in either group. Other adverse events (of unknown causality) reported included gastrointestinal symptoms in 10 patients (10.2%) in the study treatment group and 10 patients (9.9%) in the control treatment group, and infection events in 47 patients (48.0%) in the study treatment group and 32 patients (31.7%) in the control treatment group.

The primary endpoint was the incidence of diarrhea rated Bristol Scale 5 or higher within 3 days after initiation of the study drug. The analysis included 97 patients in the test treatment group and 99 in the control treatment group. The diarrhea incidence rates were 38.1% and 49.5%, respectively. The difference in rates was -11.4%, with a 95% confidence interval of -25.2 to 2.4, p=0.1094, indicating no significant difference. As an exploratory post-hoc analysis, when diarrhea was defined as Bristol Scale 6 or higher occurring within 3 days after initiation of study drug administration, the incidence rates were 29.9% and 45.5%, respectively. The difference in rates was -15.6%, with a 95% confidence interval of -28.9 to -2.2, p=0.0247, indicating a significantly lower incidence of diarrhea in the study treatment group.

No significant difference was detected for the primary outcome. No adverse events causally related to the study drug were reported in the safety analysis. In exploratory post-hoc analyses, Hynex Rinuet significantly reduced diarrhea with a Bristol Scale score of 6 or higher.

May. 31, 2026

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031230684

Yokoyama Nobuyuki

Yokohama City University Hospital

3-9 Fukuura, Kanazawa, Yokohama, Kanagawa

voth@yokohama-cu.ac.jp

Yokoyama Nobuyuki

Yokohama City University Hospital

3-9 Fukuura, Kanazawa, Yokohama, Kanagawa

+81-45-787-2918

voth@yokohama-cu.ac.jp

Complete

Mar. 08, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1)Patients admitted to ICU (regardless of reason for admission)
(2)Patients aged 18 years of age or older at the time of enrolment
(3)Patients indicated for EN by transgastric administration
(4)Patients who have given written, free and voluntary consent to participate in this study, either by themselves or by a surrogate

(1)Patients for whom EN had been performed within 30 days prior to enrollment
(2)Patients with diarrhea at enrollment; Bristol scale >=5 (Bristol scale 5, 6, or 7 points)
(3)Patients with contraindications or medical inappropriateness (including allergies) to EN by transgastric administration of this nutrient
(4)Patients with DNR/BSC policy
(5)Patients for whom EN is performed by PEG/PTEG
(6)Other cases judged as inappropriate by the investigator

Both

Patients admitted to ICU (critically ill) who need to be controlled with EN preparations

Study treatment group: HYNEX RENUTE was administered via feeding tube for 3 days.
Control treatment group: Glucerna-REX administered via feeding tube for 3 days.

EN, ICU

HYNEX RENUTE, Glucerna-REX

Incidence of diarrhea within 3 days of study product administration

1) Bristol Scale diarrhea on days 1, 2, and 3 of treatment with the test product, diarrhea(200 g/day, or 300 ml/day) and soluble diarrhea (>=3 times/day).
2) Diarrhea (as defined by Bristol Scale 5, 6, or 7) in the first week after the start of treatment with the test product
3) Failure rate of EN on days 3 and 7 of treatment with study product
4) Duration of EN administration
5) Daily energy and protein dose for EN and intravenous nutrition during the first 7 days after the start of treatment with the study product
6) Survival rate at 28 days after the start of the study product administration
7) Number of days in ICU
8) Hospitalization days
9) Number of ventilatory days
10) Nutritional endpoints: WBC, lymphocyte count, CRP, albumin, prealbumin, total cholesterol, triglycerides (days 7 and 14)
11) Barthel Index at day 28 after the start of treatment with the study product.
12) Incidence of intestinal intolerance events
13) Incidence of infectious events within 28 days of study product administration

+81-45-370-7627

Mar. 07, 2024

none