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

NCT ID: NCT06673134

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2028-07-24

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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

enteral nutrition group

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

Immunotherapy

Intervention Type: DRUG

Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc

biological agents

Intervention Type: DRUG

Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc

Glucocorticoids

Intervention Type: DRUG

Glucocorticoids treatments are given

fecal microbiota transplantation

Intervention Type: OTHER

Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc

Glucocorticoid group

Glucocorticoid therapy

enteral nutrition

Intervention Type: DRUG

exclusive enteral nutrition therapy or Partial enteral nutrition

biological agents

Intervention Type: DRUG

Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc

fecal microbiota transplantation

Intervention Type: OTHER

Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc

Immunosuppressive group

Immunosuppressive therapy

enteral nutrition

Intervention Type: DRUG

exclusive enteral nutrition therapy or Partial enteral nutrition

biological agents

Intervention Type: DRUG

Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc

fecal microbiota transplantation

Intervention Type: OTHER

Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc

Fecal Microbiota Transplantation group

Fecal Microbiota Transplantation therapy

enteral nutrition

Intervention Type: DRUG

exclusive enteral nutrition therapy or Partial enteral nutrition

Immunotherapy

Intervention Type: DRUG

Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc

biological agents

Intervention Type: DRUG

Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc

Glucocorticoids

Intervention Type: DRUG

Glucocorticoids treatments are given

Biologics group

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

enteral nutrition

Intervention Type: DRUG

exclusive enteral nutrition therapy or Partial enteral nutrition

Immunotherapy

Intervention Type: DRUG

Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc

Glucocorticoids

Intervention Type: DRUG

Glucocorticoids treatments are given

fecal microbiota transplantation

Intervention Type: OTHER

Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc

Interventions

enteral nutrition

exclusive enteral nutrition therapy or Partial enteral nutrition

Intervention Type: DRUG

Immunotherapy

Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc

Intervention Type: DRUG

biological agents

Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc

Intervention Type: DRUG

Glucocorticoids

Glucocorticoids treatments are given

Intervention Type: DRUG

fecal microbiota transplantation

Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc

Intervention Type: OTHER

Other Intervention Names

nutrition; immunosuppressor; biotherapy; glucocorticoid; Flora transplantation

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;

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Biao Zou

Attending physician, pediatric department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhihua Huang Huang, Pro

Role: STUDY_DIRECTOR

Huazhong University of Science and Technology

Locations

Tongji Hospital, Wuhan, 430030

Wuhan, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pm.yuntsg.com/details.html?pmid=29050646&key=Ng%20SC,%20Shi%20HY,%20Hamidi%20N,%20et%20al.%20worldwide%20incidence%20and%20prevalence%20of%20inflammatory%20bowel%20disease%20in%20the%2021st%20century:%20a%20systematic%20review%20of%20population-based%20studies.%20Lancet.

Mainly the incidence of IBD

Other Identifiers

63639582

Identifier Type: -

Identifier Source: org_study_id