Chronic ConstipationNCT05723731

Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

A study testing taVNS and Laxative Agent in people with Chronic Constipation, run by Air Force Military Medical University, China at 5 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Constipation
What is being tested?: taVNS and Laxative Agent
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 5 sitesChina
Study dates: 3 Jan 2023to 28 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
Complete spontaneous bowel movements (CSBMs) per week < 3;
No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.

Who cannot join

Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
Have a cardiac pacemaker implantation or other electronically implanted devices;
Prior taVNS treatment;
History of colorectal surgery, except for simple appendectomy;
Severe cardiovascular, hepatic, or renal disease;
Known malignancy;

Show all 9Show fewer

Secondary constipation caused by medications and other diseases;
Pregnant or lactating women;
Refusal to sign an informed consent.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
Lanzhou, Gansu, 730030
Department of Gastroenterology, National Clinical Research Center of Infectious Disease, The Third People's Hospital of Shenzhen, The Second Affiliated Hospital of Southern University of Science and Technology
Shenzhen, Guangdong, 518114
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Xijing 986 Hospita
Xi'an, Shaanxi, 710032
Tangdu Hospital
Xi'an, Shaanxi, 710038

Other trials in China

About this study

Official title: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Randomized Controlled Trial

The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.

Conditions: Chronic Constipation
Being tested: taVNS, Laxative Agent
Keywords: constipation
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

taVNSDevice
Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)
Laxative AgentDrug
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.

Study groups in NCT05723731
Study group	Role	What they receive
Treatment group	Experimental	patients will receive taVNS at left tragus for four weeks. Receives: Device: taVNS; Drug: Laxative Agent
Sham-treatment group	Sham comparator	patients will receive sham-taVNS at left earlobe for four weeks. Receives: Device: taVNS; Drug: Laxative Agent

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder rate
Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks
Measured: 4 weeks

Secondary outcomes (11)

Responder rate at the time of the follow-up visit
Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks
Measured: 8 weeks
CSBMs
Changes from baseline by time point in the CSBMs
Measured: 12 weeks
Spontaneous bowel movements (SBMs)
Changes from baseline by time point in the SBMs
Measured: 12 weeks
Abdominal symptoms
Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping).
Measured: 12 weeks
Bristol stool form scale (BFSF)
Changes from baseline by time point in the BFSF
Measured: 12 weeks
Laxative agents using
Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week
Measured: 12 weeks
Patient Assessment of Constipation symptom (PAC-SYM)
Changes from baseline by time point in the PAC-SYM score
Measured: 12 weeks
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Changes from baseline by time point in the PAC-QOL score
Measured: 12 weeks
Self-Rating Depression Scale (SDS)
Changes from baseline by time point in SDS scores
Measured: 12 weeks
Self-Rating Anxiety Scale (SAS)
Changes from baseline by time point in SAS scores
Measured: 12 weeks
Adverse events
Adverse events
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202328 Sep 2023

First posted13 Feb 2023
Study start3 Jan 2023
Primary completion31 Jul 2023
Study completion28 Sep 2023

Why it stopped: A pre-specified interim analysis was conducted as planned, we calculated a P-value greater than 0.57 when comparing response rates between taVNS and sham group, resulting in an early termination of the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic ConstipationStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05723731
Sponsor's protocol ID: KY20222075-F-1
Status last verified: Jul 2024
First submitted: 31 Jan 2023
Last updated: 10 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Other researchers can contact PI to get IPD.

Publications

Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
PubMed 21382575
Nag A, Martin SA, Mladsi D, Olayinka-Amao O, Purser M, Vekaria RM. The Humanistic and Economic Burden of Chronic Idiopathic Constipation in the USA: A Systematic Literature Review. Clin Exp Gastroenterol. 2020 Jul 16;13:255-265. doi: 10.2147/CEG.S239205. eCollection 2020.
PubMed 32765039
Shi X, Hu Y, Zhang B, Li W, Chen JD, Liu F. Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. JCI Insight. 2021 Jul 22;6(14):e150052. doi: 10.1172/jci.insight.150052.
PubMed 34138761
Liu T, Wang Z, Li Y, Kang X, Wang X, Ren G, Lv Y, Li J, Liu Y, Liang S, Wang X, Huang X, Zhang X, Wang J, Nie Y, Luo H, Sun J, Qin W, Han Y, Pan Y. Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Multicenter, Randomized Controlled Study. United European Gastroenterol J. 2025 Oct;13(8):1550-1559. doi: 10.1002/ueg2.70041. Epub 2025 May 13.
PubMed 40359320

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation

All Chronic Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05723731
Acronym / sponsor ID: KY20222075-F-1
Conditions: Chronic Constipation
Keywords: constipation
Study type: Interventional
Recruitment status: TerminatedReason stopped: A pre-specified interim analysis was conducted as planned, we calculated a P-value greater than 0.57 when comparing response rates between taVNS and sham group, resulting in an early termination of the study.
Enrolment: 106 participants (actual)
Lead sponsor: Air Force Military Medical University, ChinaUniversity, hospital or other
Study start: 3 Jan 2023 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 28 Sep 2023 (actual)
First posted: 13 Feb 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment group	Experimental	Device: taVNS, Drug: Laxative Agentpatients will receive taVNS at left tragus for four weeks.
Sham-treatment group	Sham comparator	Device: taVNS, Drug: Laxative Agentpatients will receive sham-taVNS at left earlobe for four weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
Complete spontaneous bowel movements (CSBMs) per week < 3;
No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.

Key exclusion criteria (9 listed)

Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
Have a cardiac pacemaker implantation or other electronically implanted devices;
Prior taVNS treatment;
History of colorectal surgery, except for simple appendectomy;
Severe cardiovascular, hepatic, or renal disease;

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
taVNSPatients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)	Device	Sham-treatment group, Treatment group
Laxative AgentBisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.	Drug	Sham-treatment group, Treatment group

Primary outcome

Responder rate
Time frame: 4 weeks
Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks

11 secondary outcomes

Responder rate at the time of the follow-up visit
Time frame: 8 weeks
CSBMs
Time frame: 12 weeks
Spontaneous bowel movements (SBMs)
Time frame: 12 weeks
Abdominal symptoms
Time frame: 12 weeks
Bristol stool form scale (BFSF)
Time frame: 12 weeks
Laxative agents using
Time frame: 12 weeks
Patient Assessment of Constipation symptom (PAC-SYM)
Time frame: 12 weeks
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Time frame: 12 weeks
Self-Rating Depression Scale (SDS)
Time frame: 12 weeks
Self-Rating Anxiety Scale (SAS)
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks

Results and safety

The study was stopped early (reason given: A pre-specified interim analysis was conducted as planned, we calculated a P-value greater than 0.57 when comparing response rates between taVNS and sham group, resulting in an early termination of the study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
Results publication: PubMed 21382575Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
Results publication: PubMed 32765039Nag A, Martin SA, Mladsi D, Olayinka-Amao O, Purser M, Vekaria RM. The Humanistic and Economic Burden of Chronic Idiopathic Constipation in the USA: A Systematic Literature Review. Clin Exp Gastroenterol. 2020 Jul 16;13:255-265. doi: 10.2147/CEG.S239205. eCollection 2020.
Results publication: PubMed 34138761Shi X, Hu Y, Zhang B, Li W, Chen JD, Liu F. Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. JCI Insight. 2021 Jul 22;6(14):e150052. doi: 10.1172/jci.insight.150052.
Derived from this study: PubMed 40359320Liu T, Wang Z, Li Y, Kang X, Wang X, Ren G, Lv Y, Li J, Liu Y, Liang S, Wang X, Huang X, Zhang X, Wang J, Nie Y, Luo H, Sun J, Qin W, Han Y, Pan Y. Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Multicenter, Randomized Controlled Study. United European Gastroenterol J. 2025 Oct;13(8):1550-1559. doi: 10.1002/ueg2.70041. Epub 2025 May 13.
Individual participant dataSharing planned: No. Other researchers can contact PI to get IPD.

Related trials for Chronic Constipation

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing taVNS and Laxative Agent in people with Chronic Constipation, run by Air Force Military Medical University, China at 5 sites 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723731, which also lists 4 linked publications.

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 10 Jul 2024.