Irritabel Bowel Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. the patient is diagnosed with Irritable Bowel Syndrome according to Rome IV criteria;duration >=1 year; the digestive symptoms are not alleviated with conventional therapy in the past six month; Hamilton Depression Scale (HAM-D) score 20-34 and/or Hamilton Anxiety Scale (HAM-A) score 14-28; 2. aged between 18 and 80 years; male or female; 3. the patient who voluntarily participate in this study, provide written informed consent and agree with multiple clinical follow-up is available.
Exclusion criteria
Exclusion criteria: 1. Previous abdominal surgery (except cholecystectomy or appendicectomy); 2. Infection with Human immunodeficiency virus; 3. Patients with renal diseases, with the level of serum creatinine or blood urea nitrogen are 1.5 times above ULN 4. The value of any of the following liver function tests are twice above the normal upper limit (ULN): propionate transhydrogenase, aspartic acid transaminase, alkaline phosphatase or total bilirubin; 5. Patients with thyroid dysfunction , with a decrease?outside the reference range in the level of serum sensitie thyroid-stimulating hormone and serum T4 without thyroid drug control; 6. History of mental illness (mania and schizophrenia); 7. Active Infection at the screening visit, except Clostridium Difficile infection; 8. Pregnant or breast-feeding women; 9. Usage of probiotics, prebiotics and/or antibiotics within the last 2 weeks; 10. Patients who are participating in other clinical trials at the screening visit or within 3 months, and other conditions that might interfere with the patients or study as determined by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS-SSS;Hamilton anxiety scale;Hamilton depression scale;IBS-QoL; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol stool scale;diversity and relative abundance of gut microbiota; metabolites in stool;mitabolites in serum; | — |
Countries
China
Contacts
Pingxiang People's Hospital