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NCT Number: NCT07683364

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

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.

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Key information

Conditions

Critical Illness Diarrhea Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Routine ICU Enteral Nutrition Care

Other

Standard ICU nursing for enteral nutrition without systematic BSFS assessment.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Duration of diarrhea

    Time frame: Day 1 to Day 7

    Cumulative hours meeting the diarrhea definition.

  2. Incidence and severity of incontinence-associated dermatitis

    Time frame: Day 1 to Day 7

    Proportion developing IAD and severity grade.

  3. ICU length of stay

    Time frame: Through study completion, up to Day 14

    Days in ICU.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Li

CONTACT

[email protected]

+86 158 0928 5776

Shuai Qiao

CONTACT

[email protected]

+86 13598089070

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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