ulcerative colitis
Conditions
Interventions
Study group:Basic treatment,oral PRS-207 gut microbiota capsule
Control group:Basic treatment+placebo capsules
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before the start of any research procedure, voluntarily sign a written informed consent form approved by the Ethics Committee to consent to the participants in this study. 2. Subjects who are able to understand and comply with the program requirements and agree to participate in all study visits. 3. Age 18-75 years old, male or female. 4. Ulcerative colitis is diagnosed for more than 3 months according to symptoms, laboratory examination indicators, endoscopic and histological criteria; 5. According to the Mayo score, it is consistent with mild and moderate ulcerative colitis; 6. For patients with ulcerative colitis who are currently receiving the following treatment, they receive a stable dose of administration within a specified period of time, and the total score of Mayo is 4-10 points, and the score of each child is = 1 point, and the subjects can participate in this study: - oral mesalazine (stable dose before baseline= 4 weeks); - Oral prednisolone or equivalent (20 mg / day before baseline =, stable dose = 2 weeks). During the trial, patients still need to continue treatment with a stable dose of ulcerative colitis, but a mandatory reduction of 2.5 mg per week of prednisolone is required to ensure that a hormone-free state is reached at week 8.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical studies in the 4 weeks before taking the research drug for the first time; 2. Pregnant and nursing women, or female patients with birth plans during the study period; 3. Subjects who cannot undergo colonoscopy; 4. Subjects with clinical manifestations diagnosed as unsettled colitis; 5. Diagnosis of severe ulcerative colitis or a history of toxic megacolon; 6. UC basic drugs do not conform to the combination drug regimen set by the study; 7. Diagnosed with Clostridium difficile colitis or other infectious enteritis (tuberculosis, EBV, CMV) in the past 3 months; 8. A history of gastrointestinal surgery other than appendectomy, such as colectomy, or subjects who may need surgery during the study; 9. Subjects receiving the following treatment: - Treatment with intravenous corticosteroids, or corticosteroids for rectal administration or 5-ASA rectal preparations within 2 weeks before baseline; - Treatment with thalidomide within 4 weeks before baseline; - Treatment with biologics within 8 weeks of baseline (including infliximab, adalimumab, vidlizumab, usinumab, etc.); - Treatment with various intravenous or oral antibiotics within 4 weeks of baseline; - Receive probiotic medicines, food and health supplements within 4 weeks of baseline; 10. Patients with allergy to amoxicillin; 11. Subjects with bipolar disorder, somatic form disorder, personality disorder, schizophrenia or other psychiatric disorders. 12. Patients with severe cardiovascular diseases, respiratory, blood, liver and kidney, other serious diseases of the digestive tract, congenital or acquired immunodeficiency or immunosuppression due to other diseases; 13. Abnormal results of any of the following laboratory tests during screening: - Upper limit of 2x normal value (ULN) > AST, ALT - Total bilirubin > 2 times ULS - Creatinine > 2 times ULLN - Platelets 1.5 times ULP. The researchers believe that there are any other reasons why the subjects are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response: the overall Mayo score =2 and the score for each sub-item = 1;Endoscopic remission: Mayo endoscopic score = 1 or uceis = 1);Histology Mitigation: Geboes scored < 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response: mayo score decreases by =3 points, or Mayo score decreases =50% for children with blood and bowel movements;Endoscopic response: Mayo endoscopic score decreased from baseline= 1-point or UCCAIS decreased by = 3 points or UCCAIS decreased by 50% from baseline;Changes in biological indicators at 8 weeks after treatment: changes in fecal calcitein, CRP, ESR, Hb, PLT and other indicators compared to baseline;Percentage of participants maintaining clinical response/response 24 weeks (6 months) after treatment, and change in biological indicators compared to baseline;Changes in intestinal flora after 8 weeks of treatment: 16s RNA detected changes in intestinal flora structure and abundance compared to baseline;Changes in plasma metabolites after 8 weeks of treatment: non-directed metabolomics tests analyze changes in metabolites compared to baseline;Correlation analysis of changes in intestinal flora and changes in metabolites; | — |
Countries
China
Contacts
Public ContactZhang Hongjie
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed