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Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

Primary Purpose

Chronic Constipation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
taVNS
Laxative Agent
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring constipation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gastroenterology, Second Affiliated Hospital, Lanzhou UniversityRecruiting
  • 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 TechnologyRecruiting
  • Endoscopic center, Xijing Hospital of Digestive DiseasesRecruiting
  • Xijing 986 HospitaRecruiting
  • Tangdu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Sham-treatment group

Arm Description

patients will receive taVNS at left tragus for four weeks.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Responder rate at the time of the follow-up visit
Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks
CSBMs
Changes from baseline by time point in the CSBMs
Spontaneous bowel movements (SBMs)
Changes from baseline by time point in the SBMs
Abdominal symptoms
Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping).
Bristol stool form scale (BFSF)
Changes from baseline by time point in the BFSF
Laxative agents using
Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week
Patient Assessment of Constipation symptom (PAC-SYM)
Changes from baseline by time point in the PAC-SYM score
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Changes from baseline by time point in the PAC-QOL score
Self-Rating Depression Scale (SDS)
Changes from baseline by time point in SDS scores
Self-Rating Anxiety Scale (SAS)
Changes from baseline by time point in SAS scores
Adverse events
Adverse events

Full Information

First Posted
January 31, 2023
Last Updated
February 9, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05723731
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
patients will receive taVNS at left tragus for four weeks.
Arm Title
Sham-treatment group
Arm Type
Sham Comparator
Arm Description
patients will receive sham-taVNS at left earlobe for four weeks.
Intervention Type
Device
Intervention Name(s)
taVNS
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Laxative Agent
Intervention Description
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.
Primary Outcome Measure Information:
Title
Responder rate
Description
Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Responder rate at the time of the follow-up visit
Description
Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks
Time Frame
8 weeks
Title
CSBMs
Description
Changes from baseline by time point in the CSBMs
Time Frame
12 weeks
Title
Spontaneous bowel movements (SBMs)
Description
Changes from baseline by time point in the SBMs
Time Frame
12 weeks
Title
Abdominal symptoms
Description
Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping).
Time Frame
12 weeks
Title
Bristol stool form scale (BFSF)
Description
Changes from baseline by time point in the BFSF
Time Frame
12 weeks
Title
Laxative agents using
Description
Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week
Time Frame
12 weeks
Title
Patient Assessment of Constipation symptom (PAC-SYM)
Description
Changes from baseline by time point in the PAC-SYM score
Time Frame
12 weeks
Title
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Description
Changes from baseline by time point in the PAC-QOL score
Time Frame
12 weeks
Title
Self-Rating Depression Scale (SDS)
Description
Changes from baseline by time point in SDS scores
Time Frame
12 weeks
Title
Self-Rating Anxiety Scale (SAS)
Description
Changes from baseline by time point in SAS scores
Time Frame
12 weeks
Title
Adverse events
Description
Adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanglin Pan, M.D
Phone
13991811225
Email
yanglinpan@hotmail.com
Facility Information:
Facility Name
Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang, MD
Phone
+8609318942279
Email
haungxj62@163.com
Facility Name
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
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518114
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyin Zhang
Email
xhnk-01@szsy.sustech.edu.cn
Facility Name
Endoscopic center, Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanlin Pan, M.D.
Phone
86-29-84771536
Email
yanglinpan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, M.D.
Facility Name
Xijing 986 Hospita
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang, M.D.
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can contact PI to get IPD.
Citations:
PubMed Identifier
21382575
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.
Results Reference
result
PubMed Identifier
32765039
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.
Results Reference
result
PubMed Identifier
34138761
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.
Results Reference
result

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Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation

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