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

NCT07683364 | Not Yet Recruiting

• 1 other identifier: K202604-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Critical Illness; Diarrhea

Keywords

Bristol Stool Form Scale; Enteral nutrition; Diarrhea; Critically ill

Outcome Measures

Primary Outcomes (2)

• Severity of enteral nutrition-associated diarrhea

  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

  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 Outcomes (3)

• Duration of diarrhea

  Day 1 to Day 7

• Incidence and severity of incontinence-associated dermatitis

  Day 1 to Day 7

• ICU length of stay

  Through study completion, up to Day 14

Study Arms (2)

Care Pathway Group

EXPERIMENTAL

Behavioral: BSFS-Based Diarrhea Care Pathway

Routine Care Group

ACTIVE COMPARATOR

Other: Routine ICU Enteral Nutrition Care

Interventions

BSFS-Based Diarrhea Care Pathway BEHAVIORAL

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.

Care Pathway Group

Routine ICU Enteral Nutrition Care OTHER

Standard ICU nursing for enteral nutrition without systematic BSFS assessment.

Routine Care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Critical Illness; Diarrhea

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

Lu Li

CONTACT

+86 158 0928 5776; lilu455699299@163.com

Shuai Qiao

CONTACT

+86 13598089070; 1255095003@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: June 15, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the main study results.
• Access Criteria: Available to researchers upon reasonable request to the principal investigator, following review and approval of the proposal by the study team.

Locations

CN (1)