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.

NCT Number	NCT07683364
Lead Sponsor	Tang-Du Hospital
Conditions	Critical Illness, Diarrhea
Enrollment	60 participants
Start Date	2026-06-15
Primary Completion	2026-07-30 (estimated)
Study Completion	2026-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-06