Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICUNCT07178626
Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients
An observational study of Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICU, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
When the subjects are admitted to the department, the researchers will monitor potential biomarkers of gastrointestinal injury before administering enteral nutrition (a small amount of blood is drawn, serum is separated by centrifugation, and the serum sample is frozen for final centralized biomarker detection), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICU
- What is being tested?
- Not applicable- observational study
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to 31 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients who can initiate early enteral nutrition
Who may be able to join
- Age ≥18 years
- Presence of one or more organ system failures within 24 hours of ICU admission (SOFA score ≥2)
- Expected ICU stay >48 hours
- Inability to take oral nutrition
- No contraindications to enteral nutrition (EN)
Who cannot join
- Patients who have already received enteral nutrition prior to gastric antral motility measurement or biomarker collection
- Receiving palliative care with expected death within 48 hours
- Pregnancy
- Participation in another clinical trial
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, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun
Yanhua Li, +86 15804301738, liyanhua@jlu.edu.cn
About this study
Official title: Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients: the BGM-FI Study
When the subjects are admitted to the department, the researchers will monitor potential biomarkers of gastrointestinal injury before administering enteral nutrition (a small amount of blood is drawn, serum is separated by centrifugation, and the serum sample is frozen for final centralized biomarker detection), and measure the antral movement index under ultrasound (300ml of warm water is injected into the stomach before measurement, and then the antral movement is observed for 6 minutes) Then, monitor whether the patient has developed feeding intolerance within 7 days of the ICU
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
This is a prospective observational study and does not involve any intervention measures
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients who initiated enteral nutrition early | Critically ill patients who initiated enteral nutrition early Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The subject developed feeding intolerance within 7 days of the ICU
The subject developed feeding intolerance (FI) within 7 days of the ICU
FI is defined as either:
- intolerance to EN due to any clinical reason (e.g., vomiting (any visible regurgitation of gastric content irrespective of the amount), high gastric residual volume (a single volume exceeds 200 ml), diarrhea (having three or more loose or liquid stools per day with a stool weight greater than 200-250 g/day (or greater than 250 ml/day)), gastrointestinal GI bleeding (any bleeding into the GI tract lumen, confirmed by macroscopic presence of blood in vomited fluids, gastric aspirate or stool), etc.), or
- FI should be considered present if at least 20 kcal/kg BW/day via enteral route cannot be reached within 72 h of feeding attempt or if enteral feeding has to be stopped for whatever clinical reason.
Measured: The first to seventh days in the ICU
Pragmatic Definition of Enteral Feeding Intolerance (EFI) - Sensitivity Analysis of the Primary Outcome
This outcome represents a sensitivity analysis for the primary outcome of feeding intolerance.
EFI is pragmatically defined as a clinician's decision to reduce the prescribed amount of enteral nutrition (EN) specifically because features of gastrointestinal dysfunction appeared during feeding.
Results from this pragmatic definition will be analyzed to test the robustness of the primary outcome and will be interpreted only as supportive evidence, not as separate primary or secondary outcomes.
Measured: From enrollment (ICU admission) through day 7 of enteral nutrition
Secondary outcomes (6)
28-day mortality
Whether the patient died on the 28th day after being admitted to the ICU
Measured: From the 1st to the 28th day after admission to the ICU
Nutritional adequacy rate on the 7th day
The probability of achieving 80% of the calorie target (25 kcal/kg/day) in enteral nutrition on the 7th day in the ICU
Measured: On the seventh day of admission to the ICU
Length of stay in the ICU
The duration (in days) of the subjects' hospital stay in the ICU
Measured: From enrollment to the patient's departure from the ICU (up to 90 days)
28-day ventilator-free days
The number of days within the first 28 days after enrollment during which the patient was alive and free from invasive mechanical ventilation.
Measured: From enrollment (ICU admission) through day 28
Incidence of Gastric Retention
The occurrence of gastric retention during the first 7 days of enteral nutrition.
Gastric retention is defined as a single gastric residual volume >200 mL measured by syringe aspiration method.
The outcome will be recorded as a binary variable (presence or absence).
Measured: From enrollment (ICU admission) through day 7 of enteral nutrition
Incidence of Diarrhea
having three or more loose or liquid stools per day with a stool weight greater than 200-250 g/day (or greater than 250 ml/day
Measured: From enrollment (ICU admission) through day 7 of enteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start20 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICUStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178626
- Sponsor's protocol ID
- BGM-FI
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients: the BGM-FI Study
- ClinicalTrials.gov ID
- NCT07178626
- Acronym / sponsor ID
- BGM-FI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
When the subjects are admitted to the department, the researchers will monitor potential biomarkers of gastrointestinal injury before administering enteral nutrition (a small amount of blood is drawn, serum is separated by centrifugation, and the serum sample is frozen for final centralized biomarker detection), and measure the antral movement index under ultrasound (300ml of warm water is injected into the stomach before measurement, and then the antral movement is observed for 6 minutes) Then, monitor whether the patient has developed feeding intolerance within 7 days of the ICU
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients who initiated enteral nutrition early | – | Other: Not applicable- observational studyCritically ill patients who initiated enteral nutrition early |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients who can initiate early enteral nutrition
Key inclusion criteria (5 listed)
- Age ≥18 years
- Presence of one or more organ system failures within 24 hours of ICU admission (SOFA score ≥2)
- Expected ICU stay >48 hours
- Inability to take oral nutrition
- No contraindications to enteral nutrition (EN)
Key exclusion criteria (4 listed)
- Patients who have already received enteral nutrition prior to gastric antral motility measurement or biomarker collection
- Receiving palliative care with expected death within 48 hours
- Pregnancy
- Participation in another clinical trial
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 |
|---|---|---|
| Not applicable- observational studyThis is a prospective observational study and does not involve any intervention measures | Other | Critically ill patients who initiated enteral nutrition early |
Primary outcome
The subject developed feeding intolerance within 7 days of the ICU
Time frame: The first to seventh days in the ICU
The subject developed feeding intolerance (FI) within 7 days of the ICU FI is defined as either: * intolerance to EN due to any clinical reason (e.g., vomiting (any visible regurgitation of gastric content irrespective of the amount), high gastric residual volume (a single volume exceeds 200 ml), diarrhea (having three or more loose or liquid stools per day with a stool weight greater than 200-250 g/day (or greater than 250 ml/day)), gastrointestinal GI bleeding (any bleeding into the GI tract lumen, confirmed by macroscopic presence of blood in vomited fluids, gastric aspirate or stool), etc.), or * FI should be considered present if at least 20 kcal/kg BW/day via enteral route cannot be reached within 72 h of feeding attempt or if enteral feeding has to be stopped for whatever clinical reason.
Pragmatic Definition of Enteral Feeding Intolerance (EFI) - Sensitivity Analysis of the Primary Outcome
Time frame: From enrollment (ICU admission) through day 7 of enteral nutrition
This outcome represents a sensitivity analysis for the primary outcome of feeding intolerance. EFI is pragmatically defined as a clinician's decision to reduce the prescribed amount of enteral nutrition (EN) specifically because features of gastrointestinal dysfunction appeared during feeding. Results from this pragmatic definition will be analyzed to test the robustness of the primary outcome and will be interpreted only as supportive evidence, not as separate primary or secondary outcomes.
6 secondary outcomes
28-day mortality
Time frame: From the 1st to the 28th day after admission to the ICU
Nutritional adequacy rate on the 7th day
Time frame: On the seventh day of admission to the ICU
Length of stay in the ICU
Time frame: From enrollment to the patient's departure from the ICU (up to 90 days)
28-day ventilator-free days
Time frame: From enrollment (ICU admission) through day 28
Incidence of Gastric Retention
Time frame: From enrollment (ICU admission) through day 7 of enteral nutrition
Incidence of Diarrhea
Time frame: From enrollment (ICU admission) through day 7 of enteral nutrition
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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?
An observational study of Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICU, run by The First Hospital of Jilin University 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Sep 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 Dong Zhang Dong Zhang (+86 15584299391, zhangdong@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The subject developed feeding intolerance within 7 days of the ICU (time frame: The first to seventh days in the ICU). 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 3 Sep 2026.