Condition: Crohn's Disease and Ulcerative Colitis · Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Patients diagnosed with moderate to severe CD or UC by the end of the study period were selected. After obtaining informed consent, treatment with infliximab-based drugs was initiated. Basic patient information and medical history were collected. The treatment process was followed, and the drug treatment plan was adjusted based on physician experience. Follow-up and disease assessments were conducted at 0, 4, 8, 16, 24, 48, and 54 weeks. At corresponding follow-up time points, blood, stool, and tissue samples were collected for gastrointestinal endoscopy, imaging examinations, laboratory tests, symptom self-assessment by participants, adverse reaction assessment, and nutritional risk screening. The efficacy and safety of IL-23 inhibitor treatment for CD or UC were comprehensively evaluated. After the study began, regular check-ups and evaluations were required when necessary or before medication administration. Venous blood samples were collected, or fecal collection boxes were provided for stool collection. When intestinal endoscopy was required for re-examination, one piece of normal and one piece of diseased intestinal mucosa tissue were collected each time. When surgery was required, two pieces of normal and two pieces of diseased intestinal mucosa tissue were collected each time. Sample collection does not affect the disease treatment and evaluation process. If any discomfort occurs during IL-23 inhibitor treatment, or if there are new changes in the condition or any un…
This description comes directly from the study's public registry record.
Jiayin Yao, Doctor · +8613826462890 · yjyin@mail2.sysu.edu.cn
Luying Wu · +8613723661113 · wuly83@mail2.sysu.edu.cn
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