Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease (CD)

Tongji Hospital

Status: Active, not recruiting

Conditions: Crohn Disease

Treatments: Other: fecal microbiota transplantation; Drug: biological agents; Drug: Glucocorticoids; Drug: enteral nutrition; Drug: Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06673134

63639582

Details and patient eligibility

About

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;

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

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;

Trial design

100 participants in 5 patient groups

enteral nutrition group

Description:

enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition

Treatment:

Drug: Immunotherapy

Drug: Glucocorticoids

Drug: biological agents

Other: fecal microbiota transplantation

Glucocorticoid group

Description:

Glucocorticoid therapy

Treatment:

Drug: enteral nutrition

Drug: biological agents

Other: fecal microbiota transplantation

Immunosuppressive group

Description:

Immunosuppressive therapy

Treatment:

Drug: enteral nutrition

Drug: biological agents

Other: fecal microbiota transplantation

Fecal Microbiota Transplantation group

Description:

Fecal Microbiota Transplantation therapy

Treatment:

Drug: Immunotherapy

Drug: enteral nutrition

Drug: Glucocorticoids

Drug: biological agents

Biologics group

Description:

Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd).

Treatment:

Drug: Immunotherapy

Drug: enteral nutrition

Drug: Glucocorticoids

Other: fecal microbiota transplantation