Crohn's disease
Conditions
Interventions
Control group:Normal dietafter initiating biologics
CD exclusion diet (CDED) group:CDED after initiating biologics
Sponsors
The general hospital of eastern millitary command
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age range: 18-75 years old; (2) Diagnosed with CD through endoscopy, pathological biopsy, CTE, MRE, etc; (3) The lesion site of Montreal CD classification is L3 type (primary lesion, or recurrent anastomotic site); (4) There are surgical indications (such as stenosis, penetration, or ineffective drug treatment), and there is a plan for blind resection and anastomosis surgery in the past week; (5) Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form. They are willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the study plan; (6) Women of childbearing age must undergo a serum pregnancy test within 7 days prior to randomization, with a negative result, and agree to use reliable and effective contraception methods during the trial period and for 5 months after the last dose. For male participants whose partners are women of childbearing age, they must agree to use reliable and effective methods of contraception during the trial period and within 5 months after the last dose.
Exclusion criteria
Exclusion criteria: (1) Emergency surgery or intraoperative stoma fecal diversion; (2) Patients who undergo unplanned surgery due to serious complications (C-D grade 3 or above) occurring in the short term (within 30 days) after surgery; (3) Refuse to consume animal protein; (4) Patients who are unable to undergo colonoscopy after surgery; (5) No need to use biologics for postoperative maintenance (such as short segment stenosis lesions); For those who are unable to initiate biologic therapy due to various reasons within 4 weeks after surgery (such as residual abdominal infection); (6) Active tuberculosis patients, or those who have received anti tuberculosis treatment within the previous year prior to randomization; (7) If hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) are positive, the patient's HBV DNA must be less than 500IU/mL; For patients with active hepatitis B, the patient is required to have received antiviral treatment for at least 14 days before randomization (according to local standards, such as entecavir or tenofovir), and agree to continue to receive effective antiviral treatment during the study period before being included in the group; (8) HIV positive, or HCV antibody positive, HCV-RNA>1000 copy number/mL; (9) Vaccination with any live vaccine (such as vaccines for infectious diseases such as influenza, chickenpox, etc.) within 28 days prior to enrollment; (10) Previously received allogeneic bone marrow transplantation or solid organ transplantation; (11) Previous history of severe allergies to monoclonal antibodies or other biological agents; (12) Participated in other interventional clinical studies within 28 days prior to enrollment; (13) Breastfeeding women cannot be included in the group. (14) Researchers determine the existence of clinically significant underlying medical conditions that may affect the administration of the study drug or adherence to the protocol; (15) Other factors deemed inappropriate by the researchers or refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative endoscopic recurrence ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative clinical recurrence after 26 weeks;Medication Adherence Rating Scale (MARS);Glasgow adherence score;Crohn's disease activity index (CDAI);Fecal microbiota;Fecal microbiome; | — |
Countries
China
Contacts
Public ContactGong Jianfeng
The general hospital of eastern millitary command
Outcome results
None listed