Enteral Feeding IntoleranceTASTE-FINCT07854236
Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
A study testing Transcutaneous auricular vagus nerve stimulation in people with Enteral Feeding Intolerance and ICU, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study will test whether electrical stimulation applied to the outer ear can improve tolerance of tube feeding in critically ill adults in the intensive care unit (ICU). Some ICU patients develop digestive problems, such as vomiting, diarrhea, or a buildup of feeding liquid in the stomach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding Intolerance, ICU
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 30 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Admission to the intensive care unit (ICU), with an expected ICU stay of at least 5 days;
- Enteral nutrition has been initiated or is planned;
- At least one of the following manifestations of gastrointestinal dysfunction: (1) Intra-abdominal hypertension: intra-abdominal pressure ≥12 mmHg on at least two measurements within 6 hours, or a mean pressure ≥12 mmHg based on at least four measurements within 24 hours; (2) Gastric retention: gastric residual volume >200 mL on a single aspiration; (3) Diarrhea: more than three loose or watery stools per day, with a total volume >250 mL/day; (4) Lower gastrointestinal paralysis: no bowel movement for at least 3 days, with bowel sounds present or absent, after exclusion of mechanical bowel obstruction; (5) Bowel dilatation on abdominal radiography, computed tomography, or bedside ultrasound: colonic diameter >6 cm, cecal diameter >9 cm, or small bowel diameter >3 cm;
- Enteral feeding intolerance confirmed during a 72-hour trial of enteral nutrition guided by the study's feeding intolerance assessment: failure to achieve an enteral energy intake of 20 kcal/kg/day within 72 hours, or discontinuation of enteral nutrition for a clinical reason, such as vomiting, diarrhea, gastrointestinal bleeding, or an intestinal fistula. Temporary interruptions for clinical procedures do not qualify;
- Written informed consent provided by the participant or a legally authorized representative.
Who cannot join
- An absolute contraindication to enteral nutrition, including but not limited to intestinal ischemia, gastrointestinal perforation, complete bowel obstruction, or active major gastrointestinal bleeding;
- Severe cardiac arrhythmia or high-grade atrioventricular block;
- An implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other implanted electronic device;
- Local infection, ulceration, skin injury, or another condition affecting the outer ear that makes transcutaneous auricular vagus nerve stimulation unsuitable;
- Pregnancy or breastfeeding;
- Expected death within 24 hours or receipt of end-of-life care.
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, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Jiancheng Zhang, zhjcheng1@126.com
About this study
Official title: Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Enteral Feeding Intolerance in Critically Ill Patients in the Intensive Care Unit: A Single-Center, Single-Blind, Randomized Controlled Trial
This study will test whether electrical stimulation applied to the outer ear can improve tolerance of tube feeding in critically ill adults in the intensive care unit (ICU). Some ICU patients develop digestive problems, such as vomiting, diarrhea, or a buildup of feeding liquid in the stomach. These problems can prevent them from receiving enough nutrition through a feeding tube. This is called enteral feeding intolerance.
The treatment being studied is called transcutaneous auricular vagus nerve stimulation (taVNS). It delivers small electrical pulses through electrodes placed on the skin of the outer ear, usually the left ear. It does not require surgery. The treatment targets a branch of the vagus nerve, which helps regulate digestion. Researchers want to find out whether adding this treatment to usual ICU care improves feeding tolerance and whether it causes side effects.
Read more
The study will enroll 60 adults aged 18 years or older with enteral feeding intolerance at one hospital. Participants will be assigned by chance to one of two groups, with an equal chance of joining either group:
- Usual ICU care alone.
- Usual ICU care plus ear stimulation for 60 minutes once daily for five days.
Stimulation will stop earlier if a participant leaves the ICU or the study team determines that it should be stopped for safety reasons.
The main measure will be the proportion of participants whose feeding intolerance improves between 24 and 120 hours after enrollment. Improvement means receiving the study's target amount of calories through tube feeding for at least 48 consecutive hours without stopping feeding because of intolerance.
Researchers will also collect blood samples and rectal swabs to study intestinal function, gut bacteria, and substances produced by the body and gut bacteria. They will record the use of pain medicines and sedatives, changes in illness severity, and possible side effects, including skin irritation, a slow heartbeat, or low blood pressure.
Study assessments and sample collection in the ICU will continue for up to seven days after enrollment, ending earlier if the participant leaves the ICU.
Follow-up at 28 and 90 days will assess survival and, at 90 days, new infections and hospital readmissions.
- Conditions
- Enteral Feeding Intolerance, ICU
- Being tested
- Transcutaneous auricular vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationDevice
Transcutaneous auricular vagus nerve stimulation will be delivered through surface electrodes over the cymba conchae and cavum conchae, preferably of the left ear, alongside standard ICU care. Stimulation parameters are 25 Hz, a pulse width of 200-500 microseconds, and an individually adjusted current, typically 0.5-2.0 mA. Sessions will last 60 minutes once daily for five consecutive days. Heart rate, blood pressure, and local skin reactions will be monitored. Stimulation will stop for intolerance or safety concerns and end early upon ICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| taVNS intervention group | Experimental | Not described Receives: Device: Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral Feeding Intolerance Response Rate
Percentage of participants who achieve an enteral energy intake of at least 20 kcal/kg/day for at least 48 consecutive hours within the assessment window, without interruption of enteral feeding due to intolerance.
Measured: 24-120 hours after enrollment
Secondary outcomes (22)
Change in Serum Citrulline Concentration
Change from baseline in serum citrulline concentration, used as a marker of intestinal function.
Measured: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in Gut Microbial Diversity Measured by the Shannon Index
Change from baseline in the Shannon diversity index of gut microbiota assessed using rectal swab samples. Higher values indicate greater microbial diversity.
Measured: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Change in Gut Microbial Richness Measured by the Chao1 Index
Change from baseline in the Chao1 richness index of gut microbiota assessed using rectal swab samples. Higher values indicate greater estimated microbial richness.
Measured: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in Gut Microbial Community Composition
Differences in gut microbial community composition over time and between groups, assessed using Bray-Curtis dissimilarity in rectal swab samples. Higher values indicate greater differences between microbial communities.
Measured: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in Relative Abundance of Gut Microbial Taxa
Changes from baseline in the relative abundance of gut microbial taxa at the phylum and genus levels, measured in rectal swab samples. Relative abundance is expressed as a percentage.
Measured: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in relative abundance of metabolites in rectal swab samples measured by liquid chromatography-tandem mass spectrometry
Changes from baseline in metabolite abundances measured by metabolomic analysis of rectal swab samples.
Measured: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in relative abundance of metabolites in plasma samples measured by liquid chromatography-tandem mass spectrometry
Changes from baseline in metabolite abundances measured by metabolomic analysis of plasma samples.
Measured: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Opioid Analgesic Use
Cumulative and mean daily opioid doses, expressed as intravenous morphine equivalents in mg and mg/day, respectively.
Measured: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
Propofol Use
Cumulative and mean daily propofol doses, expressed in mg and mg/day, respectively.
Measured: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
Benzodiazepine Use
Cumulative and mean daily benzodiazepine doses, expressed as intravenous midazolam equivalents in mg and mg/day, respectively.
Measured: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
Change in Sequential Organ Failure Assessment Score
Change from baseline in the Sequential Organ Failure Assessment (SOFA) score. Scores range from 0 to 24, with higher scores indicating more severe organ dysfunction. A negative change indicates improvement.
Measured: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in Acute Physiology and Chronic Health Evaluation II Score
Change from baseline in the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Scores range from 0 to 71, with higher scores indicating greater illness severity. A negative change indicates improvement.
Measured: Within 24 hours before enrollment and 24-120 hours after enrollment.
Vasoactive Medication Use
Percentage of participants receiving any vasoactive medication during each assessment period.
Measured: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in C-Reactive Protein Concentration
Change from baseline in blood C-reactive protein concentration, a marker of inflammation.
Measured: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in Procalcitonin Concentration
Change from baseline in blood procalcitonin concentration.
Measured: Within 24 hours before enrollment and 24-120 hours after enrollment.
Occurrence of ICU Delirium
Percentage of participants with at least one positive delirium assessment using the Confusion Assessment Method for the ICU (CAM-ICU) during the observation period.
Measured: up to 28 days after enrollment.
ICU Mortality
Percentage of participants who die from any cause during the ICU stay in which they are enrolled.
Measured: up to 28 days after enrollment.
In-Hospital Mortality
Percentage of participants who die from any cause during the hospitalization in which they are enrolled.
Measured: up to 90 days after enrollment.
28-Day All-Cause Mortality
Percentage of participants who die from any cause within 28 days after enrollment.
Measured: From enrollment through Day 28.
90-Day All-Cause Mortality
Percentage of participants who die from any cause within 90 days after enrollment.
Measured: From enrollment through Day 90.
All-Cause Hospital Readmission Within 90 Days After Discharge
Percentage of participants discharged alive from the index hospitalization who are readmitted to a hospital for any cause within 90 days after discharge.
Measured: From discharge from the index hospitalization through 90 days after discharge.
New Infections Within 90 Days
Percentage of participants who develop at least one new infection within 90 days after randomization, excluding infections present at ICU admission.
Measured: From randomization through Day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854236
- Sponsor's protocol ID
- zjc202605
- Acronym
- TASTE-FI
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Enteral Feeding Intolerance in Critically Ill Patients in the Intensive Care Unit: A Single-Center, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07854236
- Acronym / sponsor ID
- TASTE-FI / zjc202605
- Conditions
- Enteral Feeding Intolerance, ICU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Oct 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.
This study will test whether electrical stimulation applied to the outer ear can improve tolerance of tube feeding in critically ill adults in the intensive care unit (ICU). Some ICU patients develop digestive problems, such as vomiting, diarrhea, or a buildup of feeding liquid in the stomach. These problems can prevent them from receiving enough nutrition through a feeding tube. This is called enteral feeding intolerance.
The treatment being studied is called transcutaneous auricular vagus nerve stimulation (taVNS). It delivers small electrical pulses through electrodes placed on the skin of the outer ear, usually the left ear. It does not require surgery. The treatment targets a branch of the vagus nerve, which helps regulate digestion. Researchers want to find out whether adding this treatment to usual ICU care improves feeding tolerance and whether it causes side effects.
The study will enroll 60 adults aged 18 years or older with enteral feeding intolerance at one hospital. Participants will be assigned by chance to one of two groups, with an equal chance of joining either group:
- Usual ICU care alone.
- Usual ICU care plus ear stimulation for 60 minutes once daily for five days.
Stimulation will stop earlier if a participant leaves the ICU or the study team determines that it should be stopped for safety reasons.
The main measure will be the proportion of participants whose feeding intolerance improves between 24 and 120 hours after enrollment. Improvement means receiving the study's target amount of calories through tube feeding for at least 48 consecutive hours without stopping feeding because of intolerance.
Researchers will also collect blood samples and rectal swabs to study intestinal function, gut bacteria, and substances produced by the body and gut bacteria. They will record the use of pain medicines and sedatives, changes in illness severity, and possible side effects, including skin irritation, a slow heartbeat, or low blood pressure.
Study assessments and sample collection in the ICU will continue for up to seven days after enrollment, ending earlier if the participant leaves the ICU.
Follow-up at 28 and 90 days will assess survival and, at 90 days, new infections and hospital readmissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| taVNS intervention group | Experimental | Device: Transcutaneous auricular vagus nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Admission to the intensive care unit (ICU), with an expected ICU stay of at least 5 days;
- Enteral nutrition has been initiated or is planned;
- At least one of the following manifestations of gastrointestinal dysfunction: (1) Intra-abdominal hypertension: intra-abdominal pressure ≥12 mmHg on at least two measurements within 6 hours, or a mean pressure ≥12 mmHg based on at least four measurements within 24 hours; (2) Gastric retention: gastric residual volume >200 mL on a single aspiration; (3) Diarrhea: more than three loose or watery stools per day, with a total volume >250 mL/day; (4) Lower gastrointestinal paralysis: no bowel movement for at least 3 days, with bowel sounds present or absent, after exclusion of mechanical bowel obstruction; (5) Bowel dilatation on abdominal radiography, computed tomography, or bedside ultrasound: colonic diameter >6 cm, cecal diameter >9 cm, or small bowel diameter >3 cm;
- Enteral feeding intolerance confirmed during a 72-hour trial of enteral nutrition guided by the study's feeding intolerance assessment: failure to achieve an enteral energy intake of 20 kcal/kg/day within 72 hours, or discontinuation of enteral nutrition for a clinical reason, such as vomiting, diarrhea, gastrointestinal bleeding, or an intestinal fistula. Temporary interruptions for clinical procedures do not qualify;
Key exclusion criteria (6 listed)
- An absolute contraindication to enteral nutrition, including but not limited to intestinal ischemia, gastrointestinal perforation, complete bowel obstruction, or active major gastrointestinal bleeding;
- Severe cardiac arrhythmia or high-grade atrioventricular block;
- An implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other implanted electronic device;
- Local infection, ulceration, skin injury, or another condition affecting the outer ear that makes transcutaneous auricular vagus nerve stimulation unsuitable;
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulationTranscutaneous auricular vagus nerve stimulation will be delivered through surface electrodes over the cymba conchae and cavum conchae, preferably of the left ear, alongside standard ICU care. Stimulation parameters are 25 Hz, a pulse width of 200-500 microseconds, and an individually adjusted current, typically 0.5-2.0 mA. Sessions will last 60 minutes once daily for five consecutive days. Heart rate, blood pressure, and local skin reactions will be monitored. Stimulation will stop for intolerance or safety concerns and end early upon ICU discharge. | Device | taVNS intervention group |
Primary outcome
Enteral Feeding Intolerance Response Rate
Time frame: 24-120 hours after enrollment
Percentage of participants who achieve an enteral energy intake of at least 20 kcal/kg/day for at least 48 consecutive hours within the assessment window, without interruption of enteral feeding due to intolerance.
22 secondary outcomes
Change in Serum Citrulline Concentration
Time frame: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in Gut Microbial Diversity Measured by the Shannon Index
Time frame: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Change in Gut Microbial Richness Measured by the Chao1 Index
Time frame: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in Gut Microbial Community Composition
Time frame: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in Relative Abundance of Gut Microbial Taxa
Time frame: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in relative abundance of metabolites in rectal swab samples measured by liquid chromatography-tandem mass spectrometry
Time frame: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Changes in relative abundance of metabolites in plasma samples measured by liquid chromatography-tandem mass spectrometry
Time frame: Within 24 hours before enrollment, 120 hours, and 168 hours after enrollment.
Opioid Analgesic Use
Time frame: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
Propofol Use
Time frame: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
Benzodiazepine Use
Time frame: From enrollment through 120 hours after enrollment, or ICU discharge if earlier.
Change in Sequential Organ Failure Assessment Score
Time frame: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in Acute Physiology and Chronic Health Evaluation II Score
Time frame: Within 24 hours before enrollment and 24-120 hours after enrollment.
Vasoactive Medication Use
Time frame: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in C-Reactive Protein Concentration
Time frame: Within 24 hours before enrollment and 24-120 hours after enrollment.
Change in Procalcitonin Concentration
Time frame: Within 24 hours before enrollment and 24-120 hours after enrollment.
Occurrence of ICU Delirium
Time frame: up to 28 days after enrollment.
ICU Mortality
Time frame: up to 28 days after enrollment.
In-Hospital Mortality
Time frame: up to 90 days after enrollment.
28-Day All-Cause Mortality
Time frame: From enrollment through Day 28.
90-Day All-Cause Mortality
Time frame: From enrollment through Day 90.
All-Cause Hospital Readmission Within 90 Days After Discharge
Time frame: From discharge from the index hospitalization through 90 days after discharge.
New Infections Within 90 Days
Time frame: From randomization through Day 90.
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 2 Oct 2026.
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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.
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation in people with Enteral Feeding Intolerance and ICU, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 6 inclusion and 6 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 2 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteral Feeding Intolerance Response Rate (time frame: 24-120 hours after enrollment). 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 2 Oct 2026.