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

July 2, 2026 updated by: Tang-Du Hospital

Construction and Evaluation of a Bristol Stool Form Scale-Based Nursing Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients: A Prospective, Randomized, Controlled, Single-Center Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ICU critically ill patient (APACHE II score ≥15).
  • Receiving enteral nutrition via nasogastric or nasojejunal tube.
  • No diarrhea in the 24 hours before enrollment (stool frequency <3/day or BSFS type <5).
  • Written informed consent provided by the patient or legal representative.

Exclusion Criteria:

  • Known allergy to components of the enteral nutrition formula used.
  • Organic bowel disease such as inflammatory bowel disease or short bowel syndrome.
  • Pre-existing diarrhea at enrollment (≥3 stools/24 h and BSFS type ≥5).
  • Severe hepatic insufficiency.
  • Clostridioides difficile infection or other stool-culture-confirmed infectious diarrhea.
  • Pregnant or lactating women.
  • Currently participating in another clinical study.
  • Any other condition deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Care Pathway Group
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.
Active Comparator: Routine Care Group
Other: Routine ICU Enteral Nutrition Care
Standard ICU nursing for enteral nutrition without systematic BSFS assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of enteral nutrition-associated diarrhea
Time Frame: Daily across the observation period (Day 1 to Day 7)
Diarrhea severity rated by the Hart scoring method; each stool over 24 h is scored and summed for a daily total; total ≥12 indicates diarrhea. Rated by independent blinded assessors.
Daily across the observation period (Day 1 to Day 7)
Incidence of ENAD
Time Frame: Day 1 to Day 7
Proportion meeting the diarrhea definition (Hart ≥12, or ≥3 stools/24 h with BSFS ≥5, or stool ≥500 g/24 h).
Day 1 to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of diarrhea
Time Frame: Day 1 to Day 7
Cumulative hours meeting the diarrhea definition.
Day 1 to Day 7
Incidence and severity of incontinence-associated dermatitis
Time Frame: Day 1 to Day 7
Proportion developing IAD and severity grade.
Day 1 to Day 7
ICU length of stay
Time Frame: Through study completion, up to Day 14
Days in ICU.
Through study completion, up to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 28, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K202604-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the primary study results will be made available beginning 6 months after publication of the main findings. Data will be available to researchers whose proposed use has been reviewed and approved by the study team; requests should be directed to the principal investigator.

IPD Sharing Time Frame

Beginning 6 months after publication of the main study results.

IPD Sharing Access Criteria

Available to researchers upon reasonable request to the principal investigator, following review and approval of the proposal by the study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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