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Clinical Trials/NCT04916106
NCT04916106UnknownNot Applicable

Effect of Transcutaneous Electroacupuncture on Patients With Functional Abdominal Bloating/Distension

Second Affiliated Hospital of Xi'an Jiaotong University1 site in 1 country60 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Plasma gastrointestinal peptide level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Plasma gastrointestinal peptide level

Time Frame: after 1-month TEA treatment

CCK、SP、NPY、CGRP、Motilin

Orocecal ransit time

Time Frame: after 1-month TEA treatment

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)

Time Frame: after 1-month TEA treatment

Assessment of autonomic function with heart rate variability

Flora structure

Time Frame: after 1-month TEA treatment

an Illumina MiSeq Platform was used to sequence 16S ribosomal RNA (rRNA) gene of the total bacteria in fecal samples.

Symptom improvement rate

Time Frame: after 1 month TEA treatment

the symptom severity score with VAS and abdominal girth measurements

The percentage of the normal gastric slow waves in electrogastrograph

Time Frame: after 1 month TEA treatment

The percentage of the normal gastric slow waves in fasting 、fed states and the post-preprandial EGG power ratio

Rectal sensitivity

Time Frame: after 1-month TEA treatment

Rectal threshold for gas and defecation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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