An interventional study of BSFS-Based Diarrhea Care Pathway and Routine ICU Enteral Nutrition Care in Critical Illness and Diarrhea, sponsored by Tang-Du Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Supportive care
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 60 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Tang-Du Hospital is the lead sponsor of 167 studies on the registry; 78 are open to participants now.
Compared within Diarrhea, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: BSFS-Based Diarrhea Care Pathway
Other: Routine ICU Enteral Nutrition Care
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.
Standard ICU nursing for enteral nutrition without systematic BSFS assessment.
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.
Time frame: 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).
Time frame: Day 1 to Day 7
Duration of diarrhea
Cumulative hours meeting the diarrhea definition.
Time frame: Day 1 to Day 7
Incidence and severity of incontinence-associated dermatitis
Proportion developing IAD and severity grade.
Time frame: Day 1 to Day 7
ICU length of stay
Days in ICU.
Time frame: Through study completion, up to Day 14
Plan to share: Yes — De-identified individual participant data underlying the primary study results will be made available beginning 6 months after publication of the main findings. Data will be available to researchers whose proposed use has been reviewed and approved by the study team; requests should be directed to the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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