New Stool-Based care pathway aims to tame diarrhea in ICU patients on tube feeding
NCT ID NCT07683364
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests whether a standardized nursing care pathway, guided by the Bristol Stool Form Scale, can reduce the severity of diarrhea in critically ill patients receiving tube feeding. The pathway involves regular stool assessments and step-by-step interventions such as adjusting feeding rates or adding probiotics. Researchers will compare this approach to usual ICU care in 60 patients over a 7-day observation period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BSFS-Based Diarrhea Care Pathway
- What this could lead to
- If effective, this care pathway could provide a simple, standardized method to reduce diarrhea severity and improve comfort for ICU patients on tube feeding.
- What could go wrong
- This is a small, single-center trial with 60 participants, so results may not apply broadly. The intervention is behavioral, not a drug, so benefits may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
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