irritable bowel syndrome
Conditions
Interventions
The experimental group:The experimental group received standard therapy (trimebutine maleate 0.1g three times daily, orally 30minutes before meals) combined with the multi-strain probiotic, 1 bottle o
The control group:The control group received standard therapy (trimebutine maleate 0.1g three times daily, orally 30minutes before meals) combined with a placebo of the multi-strain probiotic, 1 bottl
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years, inclusive, regardless of gender; 2. Meeting the Rome IV diagnostic criteria for IBS: recurrent abdominal pain for at least 6 months, occurring at least 1 day per week in the last 3 months, and associated with two or more of the following: related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool; 3. Signed informed consent and willing to comply with the study protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Organic gastrointestinal disease identified by endoscopy; 2. Severe cardiac, hepatic, pulmonary, renal, hematologic, endocrine, or neurologic diseases, mental disorders, or chronic diseases requiring long-term oral medication; severe infections of the respiratory, digestive, urinary tract, or other sites; 3. Pregnant or lactating women, or individuals planning pregnancy within the next 3 months; 4. Participation in or recent planning to participate in a major dietary, exercise, or lifestyle intervention program within the past 3 months; 5. Use of antibiotics, immunosuppressants, or probiotics within the past 3 months; use of acid-suppressing drugs within the past 8 weeks; 6. Use of prokinetic agents more than 3 times per week within the past 2 weeks, or use of non-steroidal anti-inflammatory drugs, bile-acid sequestrants, or ursodeoxycholic acid within the past 2 weeks; 7. Allergic diseases, or use of antihistamines, mast-cell stabilizers, or other anti-allergic medications; 8. Personal or first-degree relative history of type 1 diabetes, celiac disease, inflammatory bowel disease, psoriasis, or other autoimmune/rheumatic disorders; 9. History of abdominal surgery (excluding appendectomy or splenectomy); 10. Known allergy to any component of the investigational product; 11. Long-term alcohol consumption (>5 years, with ethanol intake =40 g/day for males or =20 g/day for females) or heavy alcohol consumption (>80 g/day ethanol) within the past 2 weeks; 12. Participation in another interventional clinical trial within 3 months prior to screening; 13. Considered by the investigator to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of gastrointestinal symptoms;Improvement in quality of life;Improvement of anxiety;Improvement in depressive symptoms;Improvement of sleep quality ;changes in fecal microbiota and metabolites;changes in brain functional imaging;changes in peripheral blood inflammatory cytokines and neurotransmitters;changes in colonic mucosal pathology; | — |
Countries
China
Contacts
Public ContactDuan Liping
Peking University Third Hospital
Outcome results
None listed