Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-06-05
Brief Title:
Mechanisms of Electroacupuncture for Functional Dyspepsia Based on Enterotypes and Metabolomics
Sponsor:
Wuhan Central Hospital
Organization:
Wuhan Central Hospital
Study Overview
Official Title:
Mechanisms of Electroacupuncture for Functional Dyspepsia Based on Enterotypes and Metabolomics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Functional dyspepsia FD is a common and difficult clinical disease and there is currently no effective treatment plan Electroacupuncture is commonly used in clinical practice but there is a lack of high-quality clinical evidence of its effectiveness This study explores the clinical efficacy and possible mechanisms of electroacupuncture in the treatment of FD
The study set up a healthy control group and an FD group The FD group was divided into PDS type and EPS type according to their classification and received electroacupuncture and sham electroacupuncture intervention respectively Before and after intervention the clinical symptom score gastrointestinal symptom evaluation scale gastrointestinal symptom score questionnaire and functional dyspepsia quality of life scale of the participants were observed The levels of gastrointestinal hormones MTL Ghrelin 5-HT CCK PYY GLP-1 were measured and changes in fecal microbiota diversity and SCFAs in their metabolites were also detected A follow-up visit will be conducted one month after the intervention for all participants
Experiment 1 Observing the differences in various indicators between healthy individuals and FD patients Grouping ① Healthy control group 26 healthy volunteers without any intervention were tested for gastrointestinal hormone levels gut microbiota and their metabolites② FD group A total of 104 patients were included and the levels of gastrointestinal hormones gut microbiota and their metabolites were detected after inclusion The differences in gut type between the two groups of patients were analyzed
Experiment 2 Observing the Effect of Electroacupuncture on FD Patients Grouping The 104 FD patients included as required included 52 PDS type and 52 EPS type Both types of patients were randomly assigned to the electroacupuncture group and the sham electroacupuncture group with 26 patients in each group It is divided into PDS electroacupuncture group Group A PDS sham electroacupuncture group Group B EPS electroacupuncture group Group C and EPS sham electroacupuncture group Group D
① Electroacupuncture group including Group A and Group C with 26 cases each all receiving electroacupuncture treatment The patient lies on his back on the treatment bed After routine disinfection a 030X50mm or 030X40mm disposable sterile acupuncture and moxibustion needle is directly punctured into the acupoint After getting qi the needling sensation is maintained by the manipulation of leveling reinforcing and reducing Point selection Zhongwan Zusanli Neiguan and Tianshu connected to the 6805-AII electroacupuncture treatment instrument Connect one set of electrodes to Zhongwan and Tianshu acupoints with the positive electrode connected to Zhongwan acupoint and the negative electrode connected to Tianshu acupoint on one side Using dense wave pulse stimulation with a frequency of 2Hz100Hz with a stimulation intensity that the patient can tolerate 30 minutes each time treated once every other day for a total of 4 weeks
② False electroacupuncture including group B and group D with 26 cases each with shallow acupuncture After disconnecting the end of the electrode and binding it with black tape the false electrode was connected without being electrified and the rest were the same as the electroacupuncture group
The positioning of acupoints shall refer to the positioning standards in the new century national planning textbook for higher Chinese medicine colleges and universities Meridian and Acupoint Science edited by Shen Xueyong A follow-up visit will be conducted one month after the intervention for all subjects
During the intervention all subjects did not take drug treatment If the corresponding symptoms of the subjects such as abdominal pain abdominal burning early satiety and so on were significantly aggravated the subjects would be given symptomatic treatment of the emergency drug pantoprazole sodium enteric coated tablets when the investigator diagnosed that drug intervention was needed Participants can also consider choosing to seek treatment at the gastroenterology outpatient department If needed they can assist in contacting a specialist to provide corresponding professional diagnosis and treatment advice Subjects receiving emergency medication or other medications that affect gastrointestinal motility need to terminate the study If they have completed 12 course of treatment the corresponding outcome indicators should be included in the efficacy statistics
The study set up a healthy control group and an FD group The FD group was divided into PDS type and EPS type according to their classification and received electroacupuncture and sham electroacupuncture intervention respectively Before and after intervention the clinical symptom score gastrointestinal symptom evaluation scale gastrointestinal symptom score questionnaire and functional dyspepsia quality of life scale of the participants were observed The levels of gastrointestinal hormones MTL Ghrelin 5-HT CCK PYY GLP-1 were measured and changes in fecal microbiota diversity and SCFAs in their metabolites were also detected A follow-up visit will be conducted one month after the intervention for all participants
Experiment 1 Observing the differences in various indicators between healthy individuals and FD patients Grouping ① Healthy control group 26 healthy volunteers without any intervention were tested for gastrointestinal hormone levels gut microbiota and their metabolites② FD group A total of 104 patients were included and the levels of gastrointestinal hormones gut microbiota and their metabolites were detected after inclusion The differences in gut type between the two groups of patients were analyzed
Experiment 2 Observing the Effect of Electroacupuncture on FD Patients Grouping The 104 FD patients included as required included 52 PDS type and 52 EPS type Both types of patients were randomly assigned to the electroacupuncture group and the sham electroacupuncture group with 26 patients in each group It is divided into PDS electroacupuncture group Group A PDS sham electroacupuncture group Group B EPS electroacupuncture group Group C and EPS sham electroacupuncture group Group D
① Electroacupuncture group including Group A and Group C with 26 cases each all receiving electroacupuncture treatment The patient lies on his back on the treatment bed After routine disinfection a 030X50mm or 030X40mm disposable sterile acupuncture and moxibustion needle is directly punctured into the acupoint After getting qi the needling sensation is maintained by the manipulation of leveling reinforcing and reducing Point selection Zhongwan Zusanli Neiguan and Tianshu connected to the 6805-AII electroacupuncture treatment instrument Connect one set of electrodes to Zhongwan and Tianshu acupoints with the positive electrode connected to Zhongwan acupoint and the negative electrode connected to Tianshu acupoint on one side Using dense wave pulse stimulation with a frequency of 2Hz100Hz with a stimulation intensity that the patient can tolerate 30 minutes each time treated once every other day for a total of 4 weeks
② False electroacupuncture including group B and group D with 26 cases each with shallow acupuncture After disconnecting the end of the electrode and binding it with black tape the false electrode was connected without being electrified and the rest were the same as the electroacupuncture group
The positioning of acupoints shall refer to the positioning standards in the new century national planning textbook for higher Chinese medicine colleges and universities Meridian and Acupoint Science edited by Shen Xueyong A follow-up visit will be conducted one month after the intervention for all subjects
During the intervention all subjects did not take drug treatment If the corresponding symptoms of the subjects such as abdominal pain abdominal burning early satiety and so on were significantly aggravated the subjects would be given symptomatic treatment of the emergency drug pantoprazole sodium enteric coated tablets when the investigator diagnosed that drug intervention was needed Participants can also consider choosing to seek treatment at the gastroenterology outpatient department If needed they can assist in contacting a specialist to provide corresponding professional diagnosis and treatment advice Subjects receiving emergency medication or other medications that affect gastrointestinal motility need to terminate the study If they have completed 12 course of treatment the corresponding outcome indicators should be included in the efficacy statistics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None