Diarrhea predominant irritable bowel syndrom
Conditions
Interventions
Experimental group:Bifidobacterium quadruple viable tablets
Control group:placebo
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. Patients participated voluntarily and signed informed consent; 2. Aged 18-65 years old; 3. Patients were diagnosed as diarrhea predominant irritable bowel syndrome (IBS-D) by Rome IV criteria; 4. After two weeks of screening (7 days before the beginning of treatment), patients have abdominal pain at least 2 days a week, and the mean value of the most severe abdominal pain was more than 3 (11- NRS report). Meanwhile, the fecal traits were classified as type 6 or 7 at least 2 days; 5. During the screening period (14 + 3 days before the onset of treatment), the patients completed the symptom log for at least 10 days; 6. Patients discontinued the drugs used in the pre screening stage for abdominal symptoms or diarrhea; 7. The lifestyle during the visit did not make any significant changes in the symptoms of diarrhea and abdominal pain (for example, starting a new diet, or changing the usual exercise pattern); 8. 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
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of overall symptom relief;Frequency of defecation;Abdominal distension (with bowel sounds, accompanied by increased gas or frequent belching);Urgency of defecation;Use of remedial drugs;Quality of life (IBS-QOL scale);Changes in the score of Hamilton's anxiety and depression;Changes of microbiota and metabonomics; | — |
Primary
| Measure | Time frame |
|---|---|
| Effective treatment; | — |
Countries
China
Contacts
Public ContactXiaohua Hou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed