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Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension

Primary Purpose

Functional Abdominal Bloating/Distension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous Electroacupuncture
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Abdominal Bloating/Distension focused on measuring Functional Bloating/Distension, Transcutaneous electrical acupoint stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Clinical diagnosis of Functional bloating/distension with Rome IV;
  2. Aged 18-65 years old;

Exclusion Criteria:

  1. Have taken drugs that may affect gastrointestinal motility in the past week;
  2. Have taken antibiotics and probiotics in the past month;
  3. The history of gastrointestinal surgery;
  4. Helicobacter pylori is not cleared;
  5. Pregnant and breastfeeding women;
  6. Skin allergies.

Sites / Locations

  • The second affiliated hospital of xi'an jiaotong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

One parameter TEA group for 4 weeks

Another parameter TEA group for 4 weeks

Sham-TEA group for 2 weeks, and the random TEA for the next 2 weeks.

Arm Description

Choose two acupoints,give 25Hz electrical stimulation for 4 weeks.

Choose two acupoints,give 100 Hz electrical stimulation for 4weeks.

Choose two non-acupoints,give 25Hz and 100Hz electroacupuncture stimulation respectively for the first 2 weeks. Then give supplement TEA treatment as described above for the next 2 weeks.

Outcomes

Primary Outcome Measures

Symptom improvement rate
the symptom severity score with VAS and abdominal girth measurements
The percentage of the normal gastric slow waves in electrogastrograph
The percentage of the normal gastric slow waves in fasting 、fed states and the post-preprandial EGG power ratio
Orocecal ransit time
the lactulose hydrogen breath test was used to evaluate the intestinal transit time and observe the presence or absence of excessive small intestinal bacteria
Heart rate variability(HRV)
Assessment of autonomic function with heart rate variability
Flora structure
an Illumina MiSeq Platform was used to sequence 16S ribosomal RNA (rRNA) gene of the total bacteria in fecal samples.
Rectal sensitivity
Rectal threshold for gas and defecation
Plasma gastrointestinal peptide level
CCK、SP、NPY、CGRP、Motilin

Secondary Outcome Measures

Full Information

First Posted
May 20, 2021
Last Updated
November 16, 2021
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04916106
Brief Title
Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension
Official Title
Effect of Transcutaneous Electroacupuncture on Patients With Functional Abdominal Bloating/Distension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored.
Detailed Description
Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Rome IV was introduced in 2016. Studies have shown that bloating may affect about 30% general population and 96% of patients with functional gastrointestinal disorders (FGID).Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored. Thirty patients who fulfilled the Rome IV diagnostic criteria of FAB/D in the department of the second affiliated hospital of Xi'an jiaotong University.Inclusion criteria included: Symptoms of recurrent abdominal fullness, pressure, or a sensation of trapped gas (bloating), and/or measurable (objective) increase in abdominal girth (distention) more than 6 month;the main symptoms appeared in the past 3 months;Not taking related drugs; aged 18-65 years old;From January 2020 to December 2021; Sign informed consent. All patients were randomly assigned to 3 groups and received TEA at Zusanli (ST36) and Neiguan (PC6) with 3 diffrent parameter for 4weeks. The symptom severity score, abdominal girth, electrogastrogram (ECG) and orocecal transit time (OCTT) ,heart rate variability (HRV) ,rectal sensitivity and intestinal flora were recorded at baseline and after 2-week treatment, respectively. The symptom severity score was repeated at baseline and after 4-week treatment. Through the comparison of the index before and after TEA treatment to identify optimal stimulation parameters and explore its possible mechanism. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an jiaotong University.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Bloating/Distension
Keywords
Functional Bloating/Distension, Transcutaneous electrical acupoint stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One parameter TEA group for 4 weeks
Arm Type
Experimental
Arm Description
Choose two acupoints,give 25Hz electrical stimulation for 4 weeks.
Arm Title
Another parameter TEA group for 4 weeks
Arm Type
Experimental
Arm Description
Choose two acupoints,give 100 Hz electrical stimulation for 4weeks.
Arm Title
Sham-TEA group for 2 weeks, and the random TEA for the next 2 weeks.
Arm Type
Experimental
Arm Description
Choose two non-acupoints,give 25Hz and 100Hz electroacupuncture stimulation respectively for the first 2 weeks. Then give supplement TEA treatment as described above for the next 2 weeks.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electroacupuncture
Intervention Description
give diffrent parameter TEA treatment for 4 weeks.
Primary Outcome Measure Information:
Title
Symptom improvement rate
Description
the symptom severity score with VAS and abdominal girth measurements
Time Frame
after 1 month TEA treatment
Title
The percentage of the normal gastric slow waves in electrogastrograph
Description
The percentage of the normal gastric slow waves in fasting 、fed states and the post-preprandial EGG power ratio
Time Frame
after 1 month TEA treatment
Title
Orocecal ransit time
Description
the lactulose hydrogen breath test was used to evaluate the intestinal transit time and observe the presence or absence of excessive small intestinal bacteria
Time Frame
after 1-month TEA treatment
Title
Heart rate variability(HRV)
Description
Assessment of autonomic function with heart rate variability
Time Frame
after 1-month TEA treatment
Title
Flora structure
Description
an Illumina MiSeq Platform was used to sequence 16S ribosomal RNA (rRNA) gene of the total bacteria in fecal samples.
Time Frame
after 1-month TEA treatment
Title
Rectal sensitivity
Description
Rectal threshold for gas and defecation
Time Frame
after 1-month TEA treatment
Title
Plasma gastrointestinal peptide level
Description
CCK、SP、NPY、CGRP、Motilin
Time Frame
after 1-month TEA treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Functional bloating/distension with Rome IV; Aged 18-65 years old; Exclusion Criteria: Have taken drugs that may affect gastrointestinal motility in the past week; Have taken antibiotics and probiotics in the past month; The history of gastrointestinal surgery; Helicobacter pylori is not cleared; Pregnant and breastfeeding women; Skin allergies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Dai
Phone
13772151298
Email
daifei68@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yindi Chen
Phone
18119487105
Email
daifei68@hotmail.com
Facility Information:
Facility Name
The second affiliated hospital of xi'an jiaotong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Dai, MD
Phone
13772151298
Email
daifei68@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yindi Chen
Phone
18119487105
Email
593825787@qq.com

12. IPD Sharing Statement

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Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension

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