Mild to Moderate Active Ulcerative Colitis
Conditions
Interventions
Placebo Control Group:Probiotic preparation's placebo powder
Probiotic Observation Group:Bifidobacterium breve CCFM1369
Sponsors
Chongqing General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18-75 years old,gender is not limited; 2.Patients with mild to moderate active ulcerative colitis, with an SCCAI score 3-11, and an endoscopic UCEIS score >=1; 3.Patients have been on stable concomitant medication (5-aminosalicylic acid) for at least 4 weeks; 4.Patients voluntarily participate in this clinical trial and accept follow-up visits and other protocol requirements;
Exclusion criteria
Exclusion criteria: 1.Individuals who have used other probiotics, antibiotics, corticosteroids, and acid-suppressing medications (such as PPI inhibitors and P-CABs) within the last 4 weeks; 2.Individuals with a history of abdominal organ surgery within the last 3 months; 3.Suspected or confirmed drug abusers, and those with a history of immune deficiency (positive HIV antibodies or currently undergoing immunosuppressive therapy, etc.); 4.Individuals who have undergone bowel preparation before colonoscopy within the last 4 weeks; 5.Individuals with severe diseases in other systems such as cardiovascular, respiratory, renal, hematological, and endocrine systems; 6.Individuals with serious intestinal infections such as Clostridium difficile infection; 7.Individuals with soy protein allergies; 8.Pregnant women, nursing mothers, or women planning to become pregnant during the trial period; 9.Other situations deemed unsuitable for this clinical trial by the researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCCAI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate;Endoscopic response rate;C-reactive protein;Fecal Calprotectin; | — |
Countries
China
Contacts
Public ContactHua Yang
Chongqing General Hospital
Outcome results
None listed