跳至主要内容
临床试验/NCT04916106
NCT04916106Unknown不适用

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

Second Affiliated Hospital of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Plasma gastrointestinal peptide level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Plasma gastrointestinal peptide level

时间窗: after 1-month TEA treatment

CCK、SP、NPY、CGRP、Motilin

Orocecal ransit time

时间窗: 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)

时间窗: after 1-month TEA treatment

Assessment of autonomic function with heart rate variability

Flora structure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: after 1-month TEA treatment

Rectal threshold for gas and defecation

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital of Xi'an Jiaotong University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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