Moderate to severe active inflammatory bowel disease, including ulcerative colitis and Crohn's disease.
Conditions
Interventions
Test group:Live Bifidobacterium capsule and anti-TNF monoclonal antibody combination therapy
Control group:Anti-TNF monoclonal antibody therapy
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 14 and 65 years, regardless of gender; 2. Patients with definitively diagnosed moderate to severe active UC or CD; 3. Scheduled to initiate anti-TNF monoclonal antibody therapy (infliximab or adalimumab); 4. No use of any probiotic preparations or antimicrobial intestinal regulators within the past 4 weeks; 5. Capable of understanding and signing the informed consent form; 6. Agree to comply with the visit schedule, take medication on time, and cooperate with follow-up during the study.
Exclusion criteria
Exclusion criteria: 1. Critically ill patients with ICU hospitalization exceeding 48 hours; 2. Pregnant or lactating women; 3. Patients with severe underlying diseases, opportunistic infections, immune system deficiencies, malignant tumors, demyelinating disorders, etc. 4. Participation in other clinical trials within the past 3 months or current enrollment in other clinical trials; 5. Major abdominal surgery within the past 3 months, planned abdominal surgery, or current enterostomy status; 6. Use of probiotic/prebiotic medications or health supplements within the past 1 month; 7. Systemic antibiotic therapy (oral, intravenous, or intramuscular) within 4 weeks prior to screening, or requiring long-term/intermittent antibiotic use during the study period; 8. Active intestinal infections (e.g., Clostridium difficile infection, bacterial dysentery) requiring immediate antibiotic treatment; 9. Concurrent infections in other systems (e.g., respiratory, urinary) requiring short-term antibiotic therapy that cannot be postponed until after the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simple Endoscopic Score for Crohn's Disease;Modified Mayo Score;Pathological scoring of biopsy specimens in inflammatory bowel disease;Ulcerative Colitis Endoscopic Index of Severity;Crohn's Disease Activity Index;Serum inflammatory markers (CRP, ESR, TNF - a); | — |
Countries
China
Contacts
Public ContactZhijun Cao
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed