Clinical trial NCT05723731: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation
Official title: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Constipation
Keywords: constipation
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Responder rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Responder rate at the time of the follow-up visit
timeFrame: 8 weeks
measure: CSBMs
timeFrame: 12 weeks
measure: Spontaneous bowel movements (SBMs)
timeFrame: 12 weeks
measure: Abdominal symptoms
timeFrame: 12 weeks
measure: Bristol stool form scale (BFSF)
timeFrame: 12 weeks
measure: Laxative agents using
timeFrame: 12 weeks
measure: Patient Assessment of Constipation symptom (PAC-SYM)
timeFrame: 12 weeks
measure: Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
timeFrame: 12 weeks
measure: Self-Rating Depression Scale (SDS)
timeFrame: 12 weeks
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
state: Gansu
city: Shenzhen
country: China
facility: 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
state: Guangdong
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: Xijing 986 Hospita
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.