Functional Abdominal Bloating/DistensionNCT04916106
Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension
A study testing Transcutaneous Electroacupuncture in people with Functional Abdominal Bloating/Distension, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abdominal Bloating/Distension
- What is being tested?
- Transcutaneous Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Functional bloating/distension with Rome IV;
- Aged 18-65 years old；
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
Fei Dai, MD, 13772151298, daifei68@hotmail.com
Yindi Chen, 18119487105, 593825787@qq.com
About this study
Official title: Effect of Transcutaneous Electroacupuncture on Patients With Functional Abdominal Bloating/Distension
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.
Read the 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.
- Conditions
- Functional Abdominal Bloating/Distension
- Being tested
- Transcutaneous Electroacupuncture
- Keywords
- Functional Bloating/Distension, Transcutaneous electrical acupoint stimulation
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous ElectroacupunctureDevice
give diffrent parameter TEA treatment for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| One parameter TEA group for 4 weeks | Experimental | Choose two acupoints,give 25Hz electrical stimulation for 4 weeks. Receives: Device: Transcutaneous Electroacupuncture |
| Another parameter TEA group for 4 weeks | Experimental | Choose two acupoints,give 100 Hz electrical stimulation for 4weeks. Receives: 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. Receives: Device: Transcutaneous Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement rate
the symptom severity score with VAS and abdominal girth measurements
Measured: 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
Measured: 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
Measured: after 1-month TEA treatment
Heart rate variability（HRV）
Assessment of autonomic function with heart rate variability
Measured: 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.
Measured: after 1-month TEA treatment
Rectal sensitivity
Rectal threshold for gas and defecation
Measured: after 1-month TEA treatment
Plasma gastrointestinal peptide level
CCK、SP、NPY、CGRP、Motilin
Measured: after 1-month TEA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jan 2020
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Bloating/DistensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916106
- Sponsor's protocol ID
- 2018079
- Other IDs
- S2020-YF-YBSF-0237
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electroacupuncture on Patients With Functional Abdominal Bloating/Distension
- ClinicalTrials.gov ID
- NCT04916106
- Acronym / sponsor ID
- 2018079
- Conditions
- Functional Abdominal Bloating/Distension
- Keywords
- Functional Bloating/Distension, Transcutaneous electrical acupoint stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One parameter TEA group for 4 weeks | Experimental | Device: Transcutaneous ElectroacupunctureChoose two acupoints,give 25Hz electrical stimulation for 4 weeks. |
| Another parameter TEA group for 4 weeks | Experimental | Device: Transcutaneous ElectroacupunctureChoose two acupoints,give 100 Hz electrical stimulation for 4weeks. |
| Sham-TEA group for 2 weeks, and the random TEA for the next 2 weeks. | Experimental | Device: Transcutaneous ElectroacupunctureChoose 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Functional bloating/distension with Rome IV;
- Aged 18-65 years old；
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electroacupuncturegive diffrent parameter TEA treatment for 4 weeks. | Device | Another parameter TEA group for 4 weeks, One parameter TEA group for 4 weeks, Sham-TEA group for 2 weeks, and the random TEA for the next 2 weeks. |
Primary outcome
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
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.
Rectal sensitivity
Time frame: after 1-month TEA treatment
Rectal threshold for gas and defecation
Plasma gastrointestinal peptide level
Time frame: after 1-month TEA treatment
CCK、SP、NPY、CGRP、Motilin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
Related trials for Functional Abdominal Bloating/Distension
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
Recruiting
Visible Abdominal Distension
Irritable Bowel Syndrome, Dyspepsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electroacupuncture in people with Functional Abdominal Bloating/Distension, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Dai (13772151298, daifei68@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement rate (time frame: after 1 month TEA treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.