MedTrace Logo

Mechanisms of Electroacupuncture for Functional Dyspepsia Based on "Enterotypes" and Metabolomics

NCT05920395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-06-27

No results posted yet for this study

Summary

The goal of this clinical trial is to explore the clinical efficacy and possible mechanisms of electroacupuncture treatment for functional dyspepsia (FD). The main question it aims to answer are:

* Differences in the effects of electroacupuncture and sham electroacupuncture intervention on FD.
* Differences in gastrointestinal hormone levels and gut microbiota and their metabolites between healthy individuals and FD patients.

Participants receive electroacupuncture and sham electroacupuncture interventions respectively. Before and after the intervention, the clinical symptom score, gastrointestinal symptom evaluation scale, gastrointestinal symptom score questionnaire, and functional dyspepsia quality of life scale of the subjects will be observed. The levels of gastrointestinal hormones MTL, Ghrelin, 5-HT, CCK, PYY, and GLP-1 will be measured, as well as the changes in microbial diversity and SCFAs in their metabolites in feces, A follow-up visit will be conducted one month after the intervention for all participants.

Conditions

  • Functional Dyspepsia

Interventions

OTHER

Electro-acupuncture

Patients lie supine on the treatment bed, and after routine disinfection, a 0.30×60mm or 0.30×40mm disposable sterile acupuncture needle is inserted directly into the acupoint. Once obtaining qi, the needle is manipulated with even reinforcing and reducing techniques to maintain needle sensation. Acupoints selected include Zhongwan, Zusanli, Neiguan, and Tianshu, connected to the 6805-All electro-acupuncture therapy device. Zhongtuo and Tianshu acupoints are connected to a set of electrodes, with the positive pole connected to Zhongtuo and the negative pole connected to one side of Tianshu. The stimulation uses sparse and dense wave pulses with a frequency of 2Hz/100Hz, with the stimulation intensity determined based on individual patient tolerance. Each session lasts for 30 minutes, with a treatment frequency of once every other day, for a total of 4 weeks.

OTHER

Sham electro-acupuncture group

Shallow acupuncture needles are used and then disconnected from the electrode. They are tied with black tape and connected to the sham electrode. The device is not powered on, and the rest of the treatment is the same as the electro-acupuncture group.

Sponsors & Collaborators

  • Wuhan Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-06-30
Completion
2024-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05920395 on ClinicalTrials.gov