IBD
Conditions
Interventions
Test group:12 week standard method SNS treatment
Personalized SNS treatment after 12 weeks
12 week follow-up period
Sponsors
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Age: men and women aged 18-65. 2) UC or CD was diagnosed at least 3 months (12 weeks) before baseline. 3) UC: diagnosed as moderate-severe active UC, defined as 6-12 points of the baseline Mayo score (Table 1) and 2-3 points of the endoscopic sub-score. CD: diagnosed as moderately active CD, defined as baseline CDAI score (Table 3) = 220 and = 450. 4) It has been proved that there is insufficient response, lack of response or intolerance to at least one 5-ASA, glucocorticoids, immunosuppressants and biological agents. 5) Subjects who are currently receiving the following treatment are eligible to participate in this study as long as they receive the dose of stabilizer within the prescribed time: UC The stable dose of 5-ASA or SASP or immunosuppressive agent shall be taken orally for at least 2 weeks, and the dose shall remain stable during the study and treatment; Receive a stable dose of biological agents for at least 12 weeks; Or if it is stopped recently, it must be stopped for at least 8 weeks. CD a) Oral stable dose of 5-ASA preparation for at least 2 weeks; Or if it is stopped recently, it must be stopped for at least 2 weeks. b) Take glucocorticoid orally, with the equivalent dose of prednisone = 40 mg/day or budesonide = 9 mg/day or beclomethasone propionate = 5 mg/day, and the stable dose for at least 2 weeks; Or if it is stopped recently, it must be stopped for at least 2 weeks. c) Immunosuppressive therapy for at least 12 weeks and stable dose for at least 4 weeks; Or if it is stopped recently, it must be stopped for at least 4 weeks. d) If enteral nutrition is the main treatment for Crohn's disease, enteral nutrition must be accepted for at least 2 weeks; Or if it is stopped recently, it must be stopped for at least 2 weeks. e) If biological agents are used as the main treatment for CD, they must be treated with biological agents for at least 12 weeks; Or if it is stopped recently, it must be stopped for at least 8 weeks.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Newly treated subjects diagnosed as UC or CD (without previous treatment); 2) Subjects who have received surgical treatment for UC or CD in the past or may need surgical treatment during the study period (such as complications such as obstruction, intestinal perforation, abdominal abscess, etc.); 3) Participants had clinical symptoms of toxic megacolon and ischemic colitis; 4) Subjects with evidence of pathogenic intestinal infection, subjects with clostridium difficile or other intestinal infections (CMV, EBV, fungi, etc.) within 30 days of endoscopic screening, or subjects with positive clostridium difficile toxin test or other intestinal pathogens (CMV, EBV, fungi, etc.) screening; 5) Subjects with short bowel syndrome and stoma; 6) Screening and visiting patients who have undergone major trauma or major surgery within 4 weeks; 7) Bilirubin and transaminase (ALT AST) exceeded the upper limit of normal by 2 times during screening visit; 8) EGFR<60ml/min or dialysis patients; 9) Patients with evidence of hematopoietic dysfunction: HB<90g/L and/or WBC<3 (ANC<1.2); 10) Subjects who have or have a history of severe, progressive or uncontrolled kidney, liver, blood, digestive tract, metabolism, endocrine, lung, heart or nervous system diseases; 11) Female subjects who were pregnant during pregnancy, lactation or planned to be enrolled in the study; 12) Having malignant tumor or history of malignant tumor; 13) Subjects infected with HIV, HBV and HCV; 14) Unable to cooperate to complete the research process; 15) Have participated in other clinical medical studies within 3 months before the baseline; 16) Any other situation that the researcher believes will cause the subject to be unfit for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UC patients: After 12 weeks of standard treatment, the Mayo score of UC patients improved compared with the baseline; After 12 weeks of standard treatment, the modified Truelove and Witts scores of UC patients improved compared with the baseline.; CD patients: improvement of CDAI score of CD patients after 12 weeks of standard treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| UC patients: ?Compare the clinical response rate at week 12 using the complete Mayo score (clinical response is defined as a decrease of = 2 points and at least 30% in the complete Mayo score compared to baseline, as well as a decrease of = 1 point in the hematochezia score or an absolute value of = 1 point in the hematochezia score);UC patients: ?Compare the clinical remission rate at week 12 using the complete Mayo score (clinical remission is defined as a single score of 0 for bloody stools, = 1 for frequency of stools, and = 1 for endoscopic examination [excluding fragility]);UC patienst:?Mucosal healing rate at 12 weeks of treatment (defined as Mayo endoscopic sub score = 1 point);UC patienst:?Changes in modified Truelove and Witts scores from baseline at 12, 24, and 36 weeks of treatment;UC patienst:?Changes in clinical symptoms and biological indicators from baseline at 12, 24, and 36 weeks of treatment;CD patients: ? Clinical remission at week 12 (defined as CDAI score<150;CD patients:? Clinical response at weeks 12, 24, and 36 (defined as a decrease of = 100 points in CDAI score from baseline or CDAI<150); CD patients:? Endoscopic response at week 12 (defined as improvement of Krohn's disease simplified endoscopy score [SES-CD] by at least 50% from baseline or SES-CD score = 2);CD patients:? PRO-2 relief at weeks 12, 24, and 36 (defined as abdominal pain [AP] daily average score = 1 and defecation frequency [SF] daily average score = 3, i.e. AP = 1 and SF = 3);CD patients:? Clinical biomarker response at week 12, 24 and 36 (clinical response based on CDAI score and CRP or fecal calprotectin decrease = 50% from baseline); | — |
Countries
China
Contacts
Public ContactHou Xiaohua
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed