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Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients

NCT07683364 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-06

No results posted yet for this study

Summary

Enteral nutrition-associated diarrhea (ENAD) is one of the most common gastrointestinal complications in critically ill patients receiving enteral nutrition, with a reported incidence of 22.3%-63.1%. Current management lacks a standardized nursing process and relies on individual nurse experience. This study constructs a standardized nursing care pathway driven by the Bristol Stool Form Scale (BSFS) and evaluates, in a prospective randomized controlled design, whether it reduces the severity of ENAD compared with routine ICU care. Eligible mechanically fed ICU patients are randomized 1:1 to the care-pathway group or the routine-care group, observed for 7 days (D1-D7) with a follow-up assessment on D14. The primary endpoint is the Hart diarrhea score over the observation period.

Conditions

Interventions

BEHAVIORAL

BSFS-Based Diarrhea Care Pathway

Standardized nursing pathway: stool assessment every 4 h using the Bristol Stool Form Scale, with graded interventions (monitoring frequency, infusion-rate adjustment, formula change, probiotics, perianal skin protection, stepwise feeding resumption) triggered by stool type 5/6/7. Applied to the Care Pathway Group.

OTHER

Routine ICU Enteral Nutrition Care

Standard ICU nursing for enteral nutrition without systematic BSFS assessment.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2026-07-30
Completion
2026-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07683364 on ClinicalTrials.gov