Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

Air Force Military Medical University of People's Liberation Army

Status: Terminated

Conditions: Chronic Constipation

Treatments: Drug: Laxative Agent; Device: taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT05723731

KY20222075-F-1

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
2. Complete spontaneous bowel movements (CSBMs) per week < 3;
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.

Exclusion criteria

1. Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
2. Have a cardiac pacemaker implantation or other electronically implanted devices;
3. Prior taVNS treatment;
4. History of colorectal surgery, except for simple appendectomy;
5. Severe cardiovascular, hepatic, or renal disease;
6. Known malignancy;
7. Secondary constipation caused by medications and other diseases;
8. Pregnant or lactating women;
9. Refusal to sign an informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Treatment group

Experimental group

Description:

patients will receive taVNS at left tragus for four weeks.

Treatment:

Device: taVNS

Drug: Laxative Agent

Sham-treatment group

Sham Comparator group

Description:

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

Treatment:

Device: taVNS

Drug: Laxative Agent