Diarrhea-predominant irritable bowel syndrome
Conditions
Interventions
Probiotic Intervention Group:Bifidobacterium Quadruple Viable Tablets.? Administration: Orally, three times daily, three tablets each time, for 4 consecutive weeks.
Placebo control group:Bifidobacterium Quadruple Viable Tablets Simulant. Administration: Orally, three times daily, three tablets each time, for 4 consecutive weeks.
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 who meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome (IBS-D) and are scheduled to undergo colonoscopy. 2. Aged 18–65 years, regardless of gender. 3. IBS-SSS total score >= 175 points. 4. Able to understand and comply with the trial procedures, voluntarily participate in the trial, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients currently diagnosed with constipation-predominant, mixed-type, or unsubtyped irritable bowel syndrome (IBS). 2. Presence of alarm symptoms before screening, such as hematochezia, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, weight loss, or a family history of colorectal cancer. 3. Previous definitive diagnosis of organic gastrointestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except for polyps = half a month ago), intestinal diverticula, intestinal tumors, etc.; or current coexisting conditions such as peptic ulcer or infectious diarrhea. 4. Previous definitive diagnosis of diseases with symptoms similar to IBS, such as eosinophilic gastroenteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, or malabsorption syndrome. 5. Previous definitive diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, cholelithiasis, cirrhosis, or chronic pancreatitis. 6. Previous definitive diagnosis of diseases affecting gastrointestinal function, such as hyper- or hypothyroidism (except for those cured), endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, neurological (e.g., anorexia nervosa) or psychiatric disorders (e.g., severe depression or severe anxiety). 7. History of gastrointestinal surgery (except appendectomy and intestinal polypectomy), such as cholecystectomy. 8. History of severe cardiovascular or cerebrovascular diseases; significant abnormalities in liver or kidney function (alanine aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal, or total bilirubin > 1.5 × upper limit of normal, or creatinine above the upper limit of normal); hematopoietic system diseases; or tumors. 9. Allergic constitution or known allergy to any component of the investigational product. 10. Suspected or confirmed history of alcohol or drug abuse. 11. Received or currently receiving any other investigational drug or device therapy within the past 3 months. 12. Presence of severe psychiatric disorders or language barriers, preventing adequate understanding of the study and provision of informed consent. 13. Pregnant or lactating women. 14. Any other condition considered by the investigator to make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS-SSS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS-SSS Scale Single Item Scoring;Possible Impact Factors on the Recurrence of IBS Symptoms;Gastrointestinal Symptom Score;Abdominal pain; | — |
Countries
China
Contacts
Public ContactTao Bai
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed