Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance (TASTE-FI)

October 1, 2026 updated by: Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Wuhan, China
        • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years;
  2. Admission to the intensive care unit (ICU), with an expected ICU stay of at least 5 days;
  3. Enteral nutrition has been initiated or is planned;
  4. 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;
  5. 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;
  6. Written informed consent provided by the participant or a legally authorized representative.

Exclusion Criteria:

  1. An absolute contraindication to enteral nutrition, including but not limited to intestinal ischemia, gastrointestinal perforation, complete bowel obstruction, or active major gastrointestinal bleeding;
  2. Severe cardiac arrhythmia or high-grade atrioventricular block;
  3. An implanted cardiac pacemaker, implantable cardioverter-defibrillator, or other implanted electronic device;
  4. Local infection, ulceration, skin injury, or another condition affecting the outer ear that makes transcutaneous auricular vagus nerve stimulation unsuitable;
  5. Pregnancy or breastfeeding;
  6. Expected death within 24 hours or receipt of end-of-life care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: taVNS intervention group
Device: Transcutaneous auricular vagus nerve stimulation

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24-120 hours after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Serum Citrulline Concentration
Time Frame: Within 24 hours before enrollment and 24-120 hours after enrollment.

Change from baseline in serum citrulline concentration, used as a marker of intestinal function.
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 from baseline in the Shannon diversity index of gut microbiota assessed using rectal swab samples. Higher values indicate greater microbial diversity.
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.

Change from baseline in the Chao1 richness index of gut microbiota assessed using rectal swab samples. Higher values indicate greater estimated microbial richness.
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.

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.
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 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.
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 from baseline in metabolite abundances measured by metabolomic analysis of rectal swab samples.
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.

Changes from baseline in metabolite abundances measured by metabolomic analysis of plasma samples.
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.

Cumulative and mean daily opioid doses, expressed as intravenous morphine equivalents in mg and mg/day, respectively.
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.

Cumulative and mean daily propofol doses, expressed in mg and mg/day, respectively.
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.

Cumulative and mean daily benzodiazepine doses, expressed as intravenous midazolam equivalents in mg and mg/day, respectively.
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 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.
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.

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.
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.

Percentage of participants receiving any vasoactive medication during each assessment period.
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 from baseline in blood C-reactive protein concentration, a marker of inflammation.
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.

Change from baseline in blood procalcitonin concentration.
Within 24 hours before enrollment and 24-120 hours after enrollment.
Occurrence of ICU Delirium
Time Frame: up to 28 days after enrollment.

Percentage of participants with at least one positive delirium assessment using the Confusion Assessment Method for the ICU (CAM-ICU) during the observation period.
up to 28 days after enrollment.
ICU Mortality
Time Frame: up to 28 days after enrollment.

Percentage of participants who die from any cause during the ICU stay in which they are enrolled.
up to 28 days after enrollment.
In-Hospital Mortality
Time Frame: up to 90 days after enrollment.

Percentage of participants who die from any cause during the hospitalization in which they are enrolled.
up to 90 days after enrollment.
28-Day All-Cause Mortality
Time Frame: From enrollment through Day 28.

Percentage of participants who die from any cause within 28 days after enrollment.
From enrollment through Day 28.
90-Day All-Cause Mortality
Time Frame: From enrollment through Day 90.

Percentage of participants who die from any cause within 90 days after enrollment.
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.

Percentage of participants discharged alive from the index hospitalization who are readmitted to a hospital for any cause within 90 days after discharge.
From discharge from the index hospitalization through 90 days after discharge.
New Infections Within 90 Days
Time Frame: From randomization through Day 90.

Percentage of participants who develop at least one new infection within 90 days after randomization, excluding infections present at ICU admission.
From randomization through Day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • zjc202605

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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