Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Il… (NCT07683364) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients
China60 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of enteral nutrition-associated diarrhea
Timeframe: Daily across the observation period (Day 1 to Day 7)