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Recruiting
NCT05723731
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation
Conditions: Chronic Constipation
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 210
Sponsor: Air Force Military Medical University, China
Location: China
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.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria: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.
Source: ClinicalTrials.gov (NCT05723731). StuddyBuddy aggregates publicly available trial information.