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

NCT05920395 | Unknown DMC

• 1 other identifier: WZ22A06
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Functional Dyspepsia; Electroacupuncture; Intestinal flora

Outcome Measures

Primary Outcomes (3)

• Overall efficacy evaluation

  Refer to the efficacy criteria in the "Draft of Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Plan for Functional Dyspepsia", and evaluate the efficacy based on four levels: clinical cure, marked improvement, improvement, and inefficacy. Calculate the efficacy index based on the total symptom score. Efficacy index = {(pre-treatment total symptom score - post-treatment total symptom score) ÷ pre-treatment total symptom score} × 100%. Clinical Cure: Efficacy Index \> 85%; Marked Improvement: Efficacy Index 5%-85%; Improvement: Efficacy Index 26%-50%; Inefficacy: Efficacy Index \< 26%.

  up to 4 weeks

• Gastric electrogastrography (EGG) testing

  The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.

  baseline, pre-intervention

• Gastric electrogastrography (EGG) testing

  The Hefei Scientific Experimental Instrument Factory's GAP-24A high-resolution gastrointestinal electrogastrography analysis system is used for testing. In the fasted state, the subject lies in a supine position, and electrodes are placed on the upper abdomen at the first lead of the gastric antrum (2-4 cm to the right of the midpoint between the xiphoid process and umbilicus) and the second lead of the gastric body (3-5 cm to the left of the midpoint between the xiphoid process and umbilicus, 1 cm upward). Conductive gel is applied locally to the skin, and a baseline EGG recording is made before conducting gastric EGG evaluation. After recording for 30 minutes, subjects are given a standard meal (50% carbohydrates, 25% protein, 25% fat, total energy intake of 570kcal, and 150mL water), which they eat within 15 minutes, followed by another EGG recording 5 minutes after eating. Recording continues for 30 minutes, with a sampling frequency of 4Hz.

  up to 4 weeks

Secondary Outcomes (18)

• Gastrointestinal Symptom Rating Scale (GSRS)

  baseline, pre-intervention

• Gastrointestinal Symptom Rating Scale (GSRS)

  up to 4 weeks

• Gastrointestinal Symptom Rating Scale (GSRS)

  up to 8 weeks

• Gastrointestinal Symptom Score Questionnaire (GIS)

  baseline, pre-intervention

• Gastrointestinal Symptom Score Questionnaire (GIS)

  up to 4 weeks

Study Arms (5)

Healthy control group

NO INTERVENTION

26 healthy volunteers without any intervention, detecting gastrointestinal hormone levels and intestinal microbiota and their metabolites.

PDS electroacupuncture group

EXPERIMENTAL

Each with 26 patients who were treated with electro-acupuncture.

Other: Electro-acupuncture

PDS sham electroacupuncture group

SHAM COMPARATOR

Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode.

Other: Sham electro-acupuncture group

EPS electroacupuncture group

EXPERIMENTAL

Each with 26 patients who were treated with electro-acupuncture.

Other: Electro-acupuncture

EPS sham electroacupuncture group

SHAM COMPARATOR

Each with 26 patients. Shallow acupuncture needles are used and then disconnected from the electrode.

Other: Sham electro-acupuncture group

Interventions

Electro-acupuncture OTHER

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.

EPS electroacupuncture group; PDS electroacupuncture group

Sham electro-acupuncture group OTHER

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.

EPS sham electroacupuncture group; PDS sham electroacupuncture group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the Western medicine diagnostic criteria for FD;
• Aged 18-65 years (inclusive of 18 and 65 years old);
• Not having taken any gastrointestinal prokinetic drugs for at least 15 days before treatment, and not having participated in any other clinical studies;
• Voluntary signing of an informed consent form for this study. Note: Only patients who meet all four of the above criteria can be included in this study.

You may not qualify if:

• Pregnant or lactating women;
• Patients with severe organic digestive system diseases indicated by endoscopic examination, such as severe dysplasia or mucosal erosion, or pathological indication of malignancy;
• Patients with endocrine, cardiovascular, cerebrovascular, hematopoietic system, or neurological diseases such as diabetes, severe coronary heart disease, hypoglycemia, or hemiplegia;
• Patients with mental illness,infectious diseases, progressive malignant tumors,or life- threatening diseases;
• Patients who are afraid of acupuncture, have allergies or are allergic to medical supplies.
• Note: Patients who meet any of the above criteria will be excluded.
• Removal criteria
• Participants with poor compliance or those who withdraw from the study on their own during the treatment period, or those who use treatment methods prohibited by this protocol during the study phase;
• Participants who experience severe adverse events or complications and are unable to continue the treatment, and the trial is terminated;
• Participants who do not follow the prescribed treatment or whose data is incomplete, affecting efficacy and safety evaluation.
• Dropout criteria Participants who have been included but are unable to participate in the trial on time, or who do not follow the trial requirements, or who drop out during treatment.
• Research Termination Criteria
• If the condition worsens during the experiment or other serious illness occurs, it is determined that participation needs to be terminated or other treatments are necessary.
• If a serious adverse event occurs during the experiment that prevents further participation.
• The investigator should record the reason and time for withdrawing from the study. Those who have completed more than half of the treatment should be included in the efficacy statistics.

Sponsors & Collaborators

• Wuhan Central Hospital: lead

Central Study Contacts

Lei Tang, PhD

CONTACT

13871235994; tanglei125716@126.com

Qi Huang, PhD

CONTACT

18963950125; hq564335@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share