NCT04916106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

November 26, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

May 20, 2021

Last Update Submit

November 16, 2021

Conditions

Functional Abdominal Bloating/Distension

Keywords

Functional Bloating/DistensionTranscutaneous electrical acupoint stimulation

Outcome Measures

Primary Outcomes (7)

  • Symptom improvement rate

    the symptom severity score with VAS and abdominal girth measurements

    after 1 month TEA treatment

  • 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

    after 1 month TEA treatment

  • 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

    after 1-month TEA treatment

  • Heart rate variability（HRV）

    Assessment of autonomic function with heart rate variability

    after 1-month TEA treatment

  • Flora structure

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

    after 1-month TEA treatment

  • Rectal sensitivity

    Rectal threshold for gas and defecation

    after 1-month TEA treatment

  • Plasma gastrointestinal peptide level

    CCK、SP、NPY、CGRP、Motilin

    after 1-month TEA treatment

Study Arms (3)

One parameter TEA group for 4 weeks

EXPERIMENTAL

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

Device: Transcutaneous Electroacupuncture

Another parameter TEA group for 4 weeks

EXPERIMENTAL

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

Device: Transcutaneous Electroacupuncture

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

EXPERIMENTAL

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.

Device: Transcutaneous Electroacupuncture

Interventions

Transcutaneous ElectroacupunctureDEVICE

give diffrent parameter TEA treatment for 4 weeks.

Another parameter TEA group for 4 weeksOne parameter TEA group for 4 weeksSham-TEA group for 2 weeks, and the random TEA for the next 2 weeks.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Fei Dai

CONTACT

13772151298daifei68@hotmail.com

Yindi Chen

CONTACT

18119487105daifei68@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 7, 2021

Study Start

January 1, 2020

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

November 26, 2021

Record last verified: 2021-06

Locations

CN(1)