Preliminary Clinical Study on the Effect of Bacillus Subtilis on the Efficacy of Infliximab in Patients With Crohn's Disease

Korábbi kezelés

• Have participated in any other clinical research within the first month prior to enrollment;

Más betegség

• Patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
• Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
• Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
• The researcher determined that any other disease or condition is not suitable for patients participating in this study.

Laborértékek

• Patients with ALT or AST exceeding the normal upper limit by more than twice, and TBIL exceeding the normal upper limit by more than twice;
• Patients with creatinine clearance rate less than 60ml/min;
• The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;

Egyéb

• Participants who meet any of the following criteria are not eligible for inclusion in this study.
• Pregnant and lactating women;

• Age ≥ 18 years old, ≤ 75 years old;
• Patients clinically diagnosed with Crohn's disease shall refer to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) for diagnostic criteria;
• Patients receiving treatment with Infliximab;
• The patient is currently in the clinical active stage(CDAI≥150 or SES-CD≥3);
• Agree to participate in this study and sign an informed consent form.