Critical IllnessNCT07683364
Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients
A study testing BSFS-Based Diarrhea Care Pathway and Routine ICU Enteral Nutrition Care in people with Critical Illness and Diarrhea, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Diarrhea
- What is being tested?
- BSFS-Based Diarrhea Care Pathway and Routine ICU Enteral Nutrition Care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Lu Li, +86 158 0928 5776, lilu455699299@163.com
Shuai Qiao, +86 13598089070, 1255095003@qq.com
About this study
Official 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
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.
- Conditions
- Critical Illness, Diarrhea
- Being tested
- BSFS-Based Diarrhea Care Pathway, Routine ICU Enteral Nutrition Care
- Keywords
- Bristol Stool Form Scale, Enteral nutrition, Diarrhea, Critically ill
- Medical subject headings
- Critical Illness, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSFS-Based Diarrhea Care PathwayBehavioural
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 CareOther
Standard ICU nursing for enteral nutrition without systematic BSFS assessment.
| Study group | Role | What they receive |
|---|---|---|
| Care Pathway Group | Experimental | Not described Receives: Behavioral: BSFS-Based Diarrhea Care Pathway |
| Routine Care Group | Active comparator | Not described Receives: Other: Routine ICU Enteral Nutrition Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 1 to Day 7
Secondary outcomes (3)
Duration of diarrhea
Cumulative hours meeting the diarrhea definition.
Measured: Day 1 to Day 7
Incidence and severity of incontinence-associated dermatitis
Proportion developing IAD and severity grade.
Measured: Day 1 to Day 7
ICU length of stay
Days in ICU.
Measured: Through study completion, up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683364
- Sponsor's protocol ID
- K202604-31
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07683364
- Acronym / sponsor ID
- K202604-31
- Conditions
- Critical Illness, Diarrhea
- Keywords
- Bristol Stool Form Scale, Enteral nutrition, Diarrhea, Critically ill
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Pathway Group | Experimental | Behavioral: BSFS-Based Diarrhea Care Pathway |
| Routine Care Group | Active comparator | Other: Routine ICU Enteral Nutrition Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSFS-Based Diarrhea Care PathwayStandardized 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. | Behavioural | Care Pathway Group |
| Routine ICU Enteral Nutrition CareStandard ICU nursing for enteral nutrition without systematic BSFS assessment. | Other | Routine Care Group |
Primary outcome
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.
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).
3 secondary outcomes
Duration of diarrhea
Time frame: Day 1 to Day 7
Incidence and severity of incontinence-associated dermatitis
Time frame: Day 1 to Day 7
ICU length of stay
Time frame: Through study completion, up to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSFS-Based Diarrhea Care Pathway and Routine ICU Enteral Nutrition Care in people with Critical Illness and Diarrhea, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Li (+86 158 0928 5776, lilu455699299@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of enteral nutrition-associated diarrhea (time frame: Daily across the observation period (Day 1 to Day 7)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.