Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients
Starting soon · Not applicable
Conditions studied: Critical Illness, Diarrhea
In brief
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.
Key facts
- Study ID
- NCT07683364
- Run by
- Tang-Du Hospital
- People needed
- 60
- Starts
- 2026-06-15
- Expected to finish
- 2026-08-30
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China
Full record on ClinicalTrials.gov
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