Clinical trial NCT04916106: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Abdominal Bloating/Distension
Keywords: Functional Bloating/Distension
Transcutaneous electrical acupoint stimulation
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptom improvement rate
timeFrame: after 1 month TEA treatment
measure: The percentage of the normal gastric slow waves in electrogastrograph
timeFrame: after 1 month TEA treatment
measure: Orocecal ransit time
timeFrame: after 1-month TEA treatment
measure: Heart rate variability（HRV）
timeFrame: after 1-month TEA treatment
measure: Flora structure
timeFrame: after 1-month TEA treatment
measure: Rectal sensitivity
timeFrame: after 1-month TEA treatment
measure: Plasma gastrointestinal peptide level
timeFrame: after 1-month TEA treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of xi'an jiaotong university
state: Shaanxi
Study officials:
References: