Ulcerative Colitis
Conditions
Interventions
Experimental group:Mesalazine sustained-release granules +KEIB047 probiotics
control group:Mesalazine sustained-release granules +KEIB047 probiotic placebo
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? Previous diagnosis and initial diagnosis were mild to moderately active ulcerative colitis with UC involving at least the rectosigmoid region: total Mayo score of 3 to 10, Mayo internal mirror score =1, and Mayo defecation sub-score =1; ? Age 18-65 years old (including 18 and 65 years old), male or female; ? Sign the informed consent form.
Exclusion criteria
Exclusion criteria: ? Mayo with a total score of 11-12; ? Crohn's disease, intestinal tuberculosis, other chronic intestinal infectious diseases, intestinal malignancies and other diseases; ? Significant abnormal liver function, defined as serum ALT or AST = 2 times the upper limit of normal; ? Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); ? Use of biologics (infliximab, adalimumab, golizumab, cetuzumab, vitolizumab, ulinumab, or natalizumab) within 3 months prior to screening; ? Antibiotic use within 2 weeks prior to screening; ? Do not stop steroid or mesalazine enema/suppository before screening; ? Changes in oral mesalazine dose within 4 weeks prior to screening; ? Have had major abdominal surgery, especially gastrointestinal surgery; Or patients in need of hospitalization and urgent surgery; ? Patients with severe liver, kidney, endocrine, respiratory, neurological or cardiovascular diseases; ? Use of prescription or over-the-counter probiotics within 2 weeks prior to screening; ? Allergic reaction to KEIB047 probiotics or mesalazine ingredients; ? Alcohol or drug abuse; ? Recent pregnant women (both male and female), pregnant or lactating women; ? Subjects who have convulsive symptoms or major mental disorders, have difficulty controlling their movements, and are unable to cooperate; ? Patients receiving any investigational drug in a clinical trial within the 3 months prior to screening; ? subjects who are illiterate, unable to understand the informed consent, and unable to sign the informed consent; ? patients deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission rate;Clinical remission rate;Clinical response rate;Quality of life;Inflammatory factor level;Intestinal barrier function indicators;Fecal intestinal flora analysis;Intestinal mucosal flora analysis;Fecal serum metabolomics analysis; | — |
Countries
China
Contacts
Public Contactchen youxiang
The First Affiliated Hospital of Nanchang University
Outcome results
None listed