Clinical trial NCT06673134: Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
Official title: Prospective Registry Study and Clinical Observation of Children With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Keywords: Corticosteroids
immunosuppressants
biological agents;
Exclusive enteral nutrition;
pediatric
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100

Brief summary: To evaluate the clinical manifestations, treatment options, and improved clinical outcomeof children with Crohn's disease in real-world Settings: (1) analysis of clinical manifestations; (2) probability of using the same treatment options; (3) Clinical outcome;

Detailed description: This study will aim to enroll approximately 100 patients with Crohn Disease (CD). All patients who have CD will be evaluated at the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients and guardians who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent. Before the therapeutic intervention，stool samples will be checked for ova and parasites, C. difficile toxin and fecal calprotectin (FCP). Serum tests will include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Anti-nuclear antibodies (ANA), complete blood cell count, HIV, screening for Hepatitis A, B, C (hep A IgM, hep B surface antigen and antibody, Hep C antibody), and creatinine. Fecal tests included 16S rDNA flora detection and metabolite detection. Patients with CD will undergo colonoscopy, which is considered part of standard of care for patients with ongoing inflammation and is not considered a study procedure.

Dynamic monitoring follow-up up to 102 weeks, dynamic assessment of relevant indicators, such as ESR, CRP, FCP and endoscopy, etc. This study is an observational study, without intervention in the treatment of patients. Patients will accept the treatment plan formulated by the attending physician. Treatment options include: enteral nutrition (EEN/ PEN, reason, route of administration, dose, course of treatment); glucocorticoids (reason, route of administration, dose, course of treatment); immunosuppressants (reason, route of administration, dose, course of treatment); biologics (including domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd)) (dose, duration, effectiveness, safety, and economy); fecal microbiota transplantation (cause, transplantation routes, capsule fecal transplants, dose, course of treatment); the medical costs and resource consumption of the treatment of Crohn's disease in children. The difference of efficacy of the above treatment schemes was recorded, the treatment outcome was compared, and the transformation of treatment schemes was discussed. Researchers and patients will truthfully register the corresponding data generated by clinical practice from the doctors and patients respectively, collect the laboratory examination and evaluation data of doctors during the visit, and combine the hospital visit and electronic information system. Statistical analysis was performed after follow-up.

Eligibility criteria: Inclusion Criteria:

* Children under 17 years old;
* Children with a definite diagnosis of Crohn's disease;
* Patients and their guardians must sign informed consent;

Exclusion Criteria:

* Other conditions deemed inappropriate by the doctor to participate in the study;

Primary outcomes:
measure: To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings
timeFrame: 14 weeks
Secondary outcomes:
measure: Clinical remission of different treatment regimens
timeFrame: 14 and 54 weeks
measure: Clinical response of different treatment regimens
timeFrame: 54 weeks
measure: Endoscopic response of different treatment regimens
timeFrame: 14 and 54 weeks
measure: Mucosal healing of different treatment regimens
timeFrame: 14 and 54 weeks
measure: C-reactive protein of different treatment regimens
timeFrame: 14 and 54 weeks
measure: Erythrocyte sedimentation rate of different treatment regimens
timeFrame: 14 and 54 weeks
measure: Fecal calprotectin of different treatment regimens
timeFrame: 14 and 54 weeks
measure: Intestinal flora of different treatment regimens
timeFrame: 14 and 54 weeks
Other outcomes:
measure: Effectiveness and safety
timeFrame: 102 weeks
Locations:
city: Wuhan,
country: China
facility: Tongji Hospital, Wuhan, 430030
Study officials:
affiliation: Huazhong University of Science and Technology
name: Zhihua Huang Huang, Pro
role: STUDY_DIRECTOR
References: