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Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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.

Study details

Chronic Constipation

NCT05723731

Air Force Military Medical University, China

25 January 2024

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