Irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients participated voluntarily and signed informed consent; 2. Aged 20-50 years; 3. Patients were diagnosed as diarrhea predominant and constipation predominant irritable bowel syndrome by Rome IV criteria, and healthy volunteers; 4. Colonoscopy report within two years of tertiary hospitals in China was normal or the researchers considered no clinical significance (such as chronic colitis diagnosed by congestion and edema, but no erosive ulcer; the diameter of colonic polyps was less than 3mm and the number was less than 5).
Exclusion criteria
Exclusion criteria: 1.Having intestinal organic diseases, such as inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, lactose intolerance, or other organic diseases; 2. Having history of abdominal and pelvic surgery, such as cholecystectomy (patients accepted appendectomy, patients who did not have intestinal complications after caesarean section, such as intestinal obstruction, and patients accepted endoscopic treatment of intestinal polyps can be included); 3. Having chronic pancreatitis, tumors, peptic ulcers, tuberculous peritonitis, chronic liver disease, liver cirrhosis and other digestive system non intestinal diseases (B ultrasonic diagnosis of chronic cholecystitis patients without typical biliary colic can be included); 4. Stool routine results were abnormal: fecal occult blood (+) or red blood cells (+) or white blood cells (+); 5. Having other serious systemic diseases, including serious diseases such as heart, lung, kidney and other important organs, immunomodulatory diseases, metabolic diseases (diabetes, hyperthyroidism or hypothyroidism) or malignant tumors, and other diseases such as ovarian cysts and endometriosis; 6. Laboratory tests showed significant abnormalities; (1) hemoglobin 1.5xULN and / or ALT > 1.5xULN and / or total bilirubin > 1.5xULN; 7. Patients with severe mental illness or HAMD score > 20 points, or HAMA score > 29 points; 8. Abdominal pain occurs mainly at night during screening period, patients with unexplained emaciation, fever, jaundice, bloody stool or black stool, or BMI < 17; 9. Patients with a history of drug abuse or alcohol abuse (the abnormal adaptation caused by alcohol or drug use can lead to clinical morbid state, and at least 1 manifestations in 12 months: A. Repeated use of drugs or alcohol to cause negligence or failure in work, academic or family responsibility, and B. Use drugs or alcohol repeatedly on occasions where the body is in danger. C. Legal problems related to the use of drugs or alcohol repeatedly D. Although drugs or alcohol cause social or interpersonal problems, they continue to use this substance.) and those who are allergic to the drug; 10. During the experiment, the accompanying drugs that affect gastrointestinal motility and function cannot be stopped, such as antibiotics, intestinal microecologic agents, proton pump inhibitors, etc. 11. Pregnant or breast-feeding women who plan to be pregnant during the trial period; 12. Less than 3 months after attending or completing other clinical trials; 13. Researchers think it is not suitable for the candidates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composition and diversity of gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS-SSS;IBS-QOL;GSRS;Severity of abdominal pain;Frequency of defecation;Consistency of stool; | — |
Countries
China
Contacts
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology