Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

NCT05723731 | Terminated DMC

• 1 other identifier: KY20222075-F-1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 5

Brief Summary

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

Keywords

constipation

Outcome Measures

Primary Outcomes (1)

• Responder rate

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

  4 weeks

Secondary Outcomes (11)

• Responder rate at the time of the follow-up visit

  8 weeks

• CSBMs

  12 weeks

• Spontaneous bowel movements (SBMs)

  12 weeks

• Abdominal symptoms

  12 weeks

• Bristol stool form scale (BFSF)

  12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

patients will receive taVNS at left tragus for four weeks.

Device: taVNS; Drug: Laxative Agent

Sham-treatment group

SHAM COMPARATOR

patients will receive sham-taVNS at left earlobe for four weeks.

Device: taVNS; Drug: Laxative Agent

Interventions

taVNS DEVICE

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)

Sham-treatment group; Treatment group

Laxative Agent DRUG

Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.

Sham-treatment group; Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (5)

Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University

Lanzhou, Gansu, 730030, China

Location

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, China

Location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Xijing 986 Hospita

Xi'an, Shaanxi, 710032, China

Location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

Related Publications (4)

• 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.

  PMID: 21382575 RESULT

• 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.

  PMID: 32765039 RESULT

• 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.

  PMID: 34138761 RESULT

• 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.

  PMID: 40359320 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Laxatives

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 13, 2023
• Study Start: January 3, 2023
• Primary Completion: July 31, 2023
• Study Completion: September 28, 2023
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)