New Stool-Based care pathway aims to tame diarrhea in ICU patients on tube feeding

NCT ID NCT07683364

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Critical Illness diarrheal disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Critical Care Medicine, Tangdu Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710032, China

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