Gastrointestinal DysfunctionNCT07861503
Ear-Vagus Nerve Stimulation and Body Acupuncture for Gut Motility in Elderly ICU Patients
A study testing Body Acupuncture and Transcutaneous Auricular Vagus Nerve Stimulation in people with Gastrointestinal Dysfunction and Critical Illness, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This study aims to investigate whether acupuncture, specifically a combination of body acupuncture and ear vagus nerve stimulation (taVNS), can improve gastrointestinal function in critically ill elderly patients in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gastrointestinal Dysfunction, Critical Illness
- What is being tested?
- Body Acupuncture and Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Critically ill patients admitted to the ICU with APACHE II score ≥ 15.
- NRS 2002 score ≥ 3 at ICU admission, indicating risk of malnutrition and requiring nutritional support.
- Presence of gastrointestinal dysfunction or at risk, with AGI grade I-II.
- Condition considered reversible.
- Written informed consent obtained from the participant or legal representative before any study procedures.
Who cannot join
- ICU length of stay less than 7 days.
- Presence of severe gastrointestinal disease with contraindications to enteral nutrition and inability to receive conventional medications via the enteral route, such as acute gastrointestinal bleeding, mechanical intestinal obstruction, post-abdominal surgery, or abdominal compartment syndrome.
- Skin lesions at the acupuncture sites that are not suitable for acupuncture treatment.
- Advanced malignancy with significantly shortened life expectancy.
- Participation in another clinical trial.
- The treating clinician determines that the intervention is not in the patient's best interest.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Auricular Vagus Nerve Stimulation Combined With Body Acupuncture for Gut-Brain Axis Modulation and Improved Gastrointestinal Motility in Elderly Critically Ill Patients
This study aims to investigate whether acupuncture, specifically a combination of body acupuncture and ear vagus nerve stimulation (taVNS), can improve gastrointestinal function in critically ill elderly patients in the Intensive Care Unit (ICU). Gastrointestinal motility problems, such as delayed stomach emptying and constipation, are common in elderly ICU patients and can interfere with feeding, increase infection risk, and worsen outcomes. This research will test if adding acupuncture to standard care helps patients tolerate tube feeding (enteral nutrition) faster, reduces the need for intravenous nutrition, and improves overall recovery. Participants will be randomly assigned to one of three groups: standard care alone, standard care plus body acupuncture, or standard care plus both body acupuncture and ear vagus nerve stimulation. The study will compare the time it takes to achieve target feeding goals, changes in gastrointestinal function scores, and other clinical outcomes. This single-center, prospective, randomized controlled trial will enroll 60 elderly patients from the Geriatric ICU of Jiangsu Province Hospital and aims to provide evidence for integrating traditional Chinese medicine into critical care practice.
- Conditions
- Gastrointestinal Dysfunction, Critical Illness
- Being tested
- Standard Care, Body Acupuncture, Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Standard ICU care including hemodynamic management, enteral nutrition support per protocol (energy target: 25 kcal/kg ideal body weight/day; protein target: 1.3 g/kg ideal body weight/day), and management of feeding complications such as diarrhea, abdominal distension, and gastric retention. Enteral nutrition is initiated within 24-48 hours of ICU admission.
Body AcupunctureBehavioural
Acupuncture at body acupoints including CV13 (Shangwan), CV12 (Zhongwan), CV10 (Xiawan), ST21 (Liangmen), ST25 (Tianshu), SP15 (Daheng), CV4 (Guanyuan), CV6 (Qihai), CV7 (Yinjiao), LI4 (Hegu), TE6 (Zhigou), ST36 (Zusanli), ST37 (Shangjuxu), ST41 (Jiexi), and LR3 (Taichong). Sterile disposable needles (0.25mm × 40mm) are inserted 1-1.5 cun to achieve deqi sensation, retained for 30 minutes per session, once daily.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Medium-frequency electrical stimulator (SNM-FDCM01, Ningbo Maida Medical Instruments Co., Ltd.) applied to the cymba concha region of the ear. Parameters: active period 2 seconds, rest period 3 seconds; pulse width 0.5 ms; frequency 25 Hz; intensity 0-2 mA (maximum tolerable by patient); 30 minutes per session, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | Active comparator | Standard Care Group Receives: Other: Standard Care |
| Body Acupuncture Group | Active comparator | Participants receive standard ICU care plus body acupuncture therapy. Acupuncture is performed daily by a licensed acupuncturist with 10 years of experience. Needles are inserted at acupoints including CV12, CV10, ST36, PC6, and others, retained for 30 minutes per session. The intervention continues from ICU admission until ICU discharge, death, or discontinuation of nutritional support. Receives: Other: Standard Care; Behavioral: Body Acupuncture |
| Combined Auricular VNS and Body Acupuncture Group | Experimental | Participants receive standard ICU care, body acupuncture (as described in Arm 2), and additional transcutaneous auricular vagus nerve stimulation (taVNS). A medium-frequency electrical stimulator is applied to the cymba concha region of the ear (25 Hz, 0-2 mA, 30 minutes per session, once daily). The intervention continues from ICU admission until ICU discharge, death, or discontinuation of nutritional support. Receives: Other: Standard Care; Behavioral: Body Acupuncture; Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Enteral Nutrition Target
Measured: From ICU admission up to 28 days
Secondary outcomes (12)
Change in Acute Gastrointestinal Injury (AGI) Grade
Measured: Baseline Day3 Day 7
Change in Feeding Intolerance Score (FIS)
Minimum Value: 0 (The lowest score, where all evaluation items are scored as 0).
Maximum Value: 15. The score is calculated by summing three items (abdominal distension and/or pain + nausea and/or vomiting + diarrhea). Since each item has a maximum score of 5, the theoretical maximum total score is 5 + 5 + 5 = 15.
Interpretation (Higher vs. Worse): Higher scores indicate a worse outcome. A higher score represents more severe feeding intolerance (e.g., severe abdominal distension, frequent vomiting, massive diarrhea), requiring stricter clinical management. According to the notes in the image:
0-2 points: Continue enteral nutrition, increase or maintain the original rate, and provide symptomatic treatment.
3-4 points: Continue enteral nutrition, slow down the rate, and reassess after 2 hours.
≥5 points: Suspend enteral nutrition and take corresponding management measures.
Measured: Baseline Day3 Day 7
Change in Gastrointestinal Dysfunction Score (GIDS)
Minimum Value: 0 (0 - No risk: No symptoms, or any of the listed conditions present at the time of oral intake).
Maximum Value: 4 (4 - Life-threatening: One of the listed conditions present).
Interpretation (Higher vs. Worse): Higher scores indicate a worse outcome. Higher scores represent more severe gastrointestinal dysfunction and a higher risk of mortality. The specific grades are as follows:
0 (No risk): No symptoms, or any of the following conditions present at the time of oral intake (e.g., absent bowel sounds, vomiting, gastric residual volume >200ml, etc.).
- (Increased risk): Two of the following symptoms are present (e.g., no oral intake, absent bowel sounds, vomiting, gastric residual volume >200ml, etc.).
- (Gastrointestinal dysfunction): Three or more symptoms scored as 1, OR two of the following symptoms (severe diarrhea, gastrointestinal bleeding requiring transfusion, intra-abdominal pressure >20 mmHg).
- (Gastrointestinal failure): Three or more of the followin
Measured: Baseline Day3 Day 7
Change in Intra-Abdominal Pressure (IAP)
Measured: Baseline Day3 Day 7
Change in Plasma Levels of Intestinal Injury Biomarkers (I-FABP）
ng/mL
Measured: Baseline Day 7
Change in Plasma Levels of Intestinal Injury Biomarkers (DAO）
ng/mL
Measured: Baseline and Day 7
Proportion of Participants Requiring Supplemental Parenteral Nutrition (SPN)
Measured: Day 7
Incidence of Secondary Intestinal Infections
Measured: Up to 28 days from ICU admission
Duration of Mechanical Ventilation
Measured: Up to 28 days from ICU admission
Length of ICU Stay
Measured: Up to 28 days from ICU admission
28-Day Mortality
Measured: Day 28
Change in Plasma Levels of Citrulline
μmol/L
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- 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, Qian Zhang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861503
- Sponsor's protocol ID
- 2026-SR-295
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IPD) that underlie the results reported in this article, including data dictionaries, will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 9 months and ending 36 months following article publication. Proposals should be directed to dongjiaxin1861@163.com. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Vagus Nerve Stimulation Combined With Body Acupuncture for Gut-Brain Axis Modulation and Improved Gastrointestinal Motility in Elderly Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07861503
- Acronym / sponsor ID
- 2026-SR-295
- Conditions
- Gastrointestinal Dysfunction, Critical Illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 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 aims to investigate whether acupuncture, specifically a combination of body acupuncture and ear vagus nerve stimulation (taVNS), can improve gastrointestinal function in critically ill elderly patients in the Intensive Care Unit (ICU). Gastrointestinal motility problems, such as delayed stomach emptying and constipation, are common in elderly ICU patients and can interfere with feeding, increase infection risk, and worsen outcomes. This research will test if adding acupuncture to standard care helps patients tolerate tube feeding (enteral nutrition) faster, reduces the need for intravenous nutrition, and improves overall recovery. Participants will be randomly assigned to one of three groups: standard care alone, standard care plus body acupuncture, or standard care plus both body acupuncture and ear vagus nerve stimulation. The study will compare the time it takes to achieve target feeding goals, changes in gastrointestinal function scores, and other clinical outcomes. This single-center, prospective, randomized controlled trial will enroll 60 elderly patients from the Geriatric ICU of Jiangsu Province Hospital and aims to provide evidence for integrating traditional Chinese medicine into critical care practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Other: Standard CareStandard Care Group |
| Body Acupuncture Group | Active comparator | Other: Standard Care, Behavioral: Body AcupunctureParticipants receive standard ICU care plus body acupuncture therapy. Acupuncture is performed daily by a licensed acupuncturist with 10 years of experience. Needles are inserted at acupoints including CV12, CV10, ST36, PC6, and others, retained for 30 minutes per session. The intervention continues from ICU admission until ICU discharge, death, or discontinuation of nutritional support. |
| Combined Auricular VNS and Body Acupuncture Group | Experimental | Other: Standard Care, Behavioral: Body Acupuncture, Device: Transcutaneous Auricular Vagus Nerve StimulationParticipants receive standard ICU care, body acupuncture (as described in Arm 2), and additional transcutaneous auricular vagus nerve stimulation (taVNS). A medium-frequency electrical stimulator is applied to the cymba concha region of the ear (25 Hz, 0-2 mA, 30 minutes per session, once daily). The intervention continues from ICU admission until ICU discharge, death, or discontinuation of nutritional support. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years.
- Critically ill patients admitted to the ICU with APACHE II score ≥ 15.
- NRS 2002 score ≥ 3 at ICU admission, indicating risk of malnutrition and requiring nutritional support.
- Presence of gastrointestinal dysfunction or at risk, with AGI grade I-II.
- Condition considered reversible.
Key exclusion criteria (6 listed)
- ICU length of stay less than 7 days.
- Presence of severe gastrointestinal disease with contraindications to enteral nutrition and inability to receive conventional medications via the enteral route, such as acute gastrointestinal bleeding, mechanical intestinal obstruction, post-abdominal surgery, or abdominal compartment syndrome.
- Skin lesions at the acupuncture sites that are not suitable for acupuncture treatment.
- Advanced malignancy with significantly shortened life expectancy.
- 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 |
|---|---|---|
| Standard CareStandard ICU care including hemodynamic management, enteral nutrition support per protocol (energy target: 25 kcal/kg ideal body weight/day; protein target: 1.3 g/kg ideal body weight/day), and management of feeding complications such as diarrhea, abdominal distension, and gastric retention. Enteral nutrition is initiated within 24-48 hours of ICU admission. | Other | Body Acupuncture Group, Combined Auricular VNS and Body Acupuncture Group, Standard Care Group |
| Body AcupunctureAcupuncture at body acupoints including CV13 (Shangwan), CV12 (Zhongwan), CV10 (Xiawan), ST21 (Liangmen), ST25 (Tianshu), SP15 (Daheng), CV4 (Guanyuan), CV6 (Qihai), CV7 (Yinjiao), LI4 (Hegu), TE6 (Zhigou), ST36 (Zusanli), ST37 (Shangjuxu), ST41 (Jiexi), and LR3 (Taichong). Sterile disposable needles (0.25mm × 40mm) are inserted 1-1.5 cun to achieve deqi sensation, retained for 30 minutes per session, once daily. | Behavioural | Body Acupuncture Group, Combined Auricular VNS and Body Acupuncture Group |
| Transcutaneous Auricular Vagus Nerve StimulationMedium-frequency electrical stimulator (SNM-FDCM01, Ningbo Maida Medical Instruments Co., Ltd.) applied to the cymba concha region of the ear. Parameters: active period 2 seconds, rest period 3 seconds; pulse width 0.5 ms; frequency 25 Hz; intensity 0-2 mA (maximum tolerable by patient); 30 minutes per session, once daily. | Device | Combined Auricular VNS and Body Acupuncture Group |
Primary outcome
Time to Achieve Enteral Nutrition Target
Time frame: From ICU admission up to 28 days
12 secondary outcomes
Change in Acute Gastrointestinal Injury (AGI) Grade
Time frame: Baseline Day3 Day 7
Change in Feeding Intolerance Score (FIS)
Time frame: Baseline Day3 Day 7
Change in Gastrointestinal Dysfunction Score (GIDS)
Time frame: Baseline Day3 Day 7
Change in Intra-Abdominal Pressure (IAP)
Time frame: Baseline Day3 Day 7
Change in Plasma Levels of Intestinal Injury Biomarkers (I-FABP）
Time frame: Baseline Day 7
Change in Plasma Levels of Intestinal Injury Biomarkers (DAO）
Time frame: Baseline and Day 7
Proportion of Participants Requiring Supplemental Parenteral Nutrition (SPN)
Time frame: Day 7
Incidence of Secondary Intestinal Infections
Time frame: Up to 28 days from ICU admission
Duration of Mechanical Ventilation
Time frame: Up to 28 days from ICU admission
Length of ICU Stay
Time frame: Up to 28 days from ICU admission
28-Day Mortality
Time frame: Day 28
Change in Plasma Levels of Citrulline
Time frame: Baseline and Day 7
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IPD) that underlie the results reported in this article, including data dictionaries, will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 9 months and ending 36 months following article publication. Proposals should be directed to dongjiaxin1861@163.com. To gain access, data requestors will need to sign a data access agreement.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Body Acupuncture and Transcutaneous Auricular Vagus Nerve Stimulation in people with Gastrointestinal Dysfunction and Critical Illness, run by The First Affiliated Hospital with Nanjing Medical University.
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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Qian Zhang (86+13585177907, zhangqian_907@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve Enteral Nutrition Target (time frame: From ICU admission up to 28 days). 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 6 Oct 2026.