Irritable bowel syndrome-diarrhea
Conditions
Interventions
Transcutaneous auricular vagus nerve stimulation:transcutaneous auricular vagal nerve stimulation
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and willing to comply with the trial procedures, voluntarily participate in this trial and sign the informed consent form; 2. Subjects aged 18 to 65 years old when signing the informed consent form; 3. Subjects who meet the diagnostic criteria of Rome IV for IBS-D; 4. The following criteria should be met during the screening period: a. The weekly average of the NRS score of the most severe abdominal pain intensity of IBS-D patients is >= 3.0; b. The Bristol classification of stool characteristics is 6 or 7, and >= 2 days per week; c. Complete the diary card record for at least 10 days; d. Take emergency medication (pinaverium bromide) continuously or intermittently for <= 2 days; e. Subjects who can maintain a stable life and eating habits during the trial and do not make any new major changes that may affect IBS-D symptoms (for example, starting a new diet, or changing usual living habits). f. A colonoscopy report from a domestic tertiary or higher hospital within two years is normal or has abnormal results that the researcher considers to be of no clinical significance (such as chronic colitis diagnosed due to congestion and edema, but without erosion or ulcer; colon polyps with a diameter of less than or equal to 3 mm and fewer than 5 in number).
Exclusion criteria
Exclusion criteria: 1. Subjects with gastrointestinal alarm symptoms within 14 days before screening, such as blood in stool, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, unexplained weight loss, and nocturnal diarrhea; 2. Subjects who have been previously diagnosed with organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except polyps = 0.3 cm or polyps removed >= 15 days ago), intestinal diverticula, intestinal tumors, etc., or those who are still suffering from peptic ulcers and infectious diarrhea; 3. Subjects who have been previously diagnosed with diseases that affect the digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases, diabetes, neurosis (such as anorexia nervosa, etc.) or severe mental illness (such as severe depression or severe anxiety), etc.; 4. Subjects who have been previously diagnosed with diseases with similar symptoms to IBS, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; 5. Those who have been diagnosed with non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.; 6. Those who have a history of digestive system surgery (except appendectomy and intestinal polypectomy), such as cholecystectomy, etc.; 7. Those who have a history of severe cardiovascular and cerebrovascular diseases, hematopoietic system diseases or tumors; 8. Suspected or confirmed history of alcohol or drug abuse; 9. Abnormal electrocardiogram results during the screening period or baseline: 10. From the signing of the informed consent form to the end of the observation period, drugs that affect gastrointestinal motility and function, such as prokinetics, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheals, antacids, antidepressants, antianxiety drugs, intestinal flora regulating drugs and antibiotics, etc., cannot be discontinued or planned to be used; 11. Subjects who have participated in any clinical trial and received treatment in the past 3 months; 12. Pregnant or lactating women; 13. From the signing of the informed consent form to 4 after the last treatment Within one week, the subject or the subject's partner plans to become pregnant during the trial or is unwilling to take reliable contraceptive measures for contraception; 14. Subjects who have undergone pacemaker or stent implantation; 15. Familiar with acupuncture treatment, acupoints or meridians 16. The researcher believes that the subject has other conditions that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain relief response rate;Bristol stool improvement rate; | — |
Countries
China
Contacts
Public ContactLiu Shi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed