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

Prospective Registry Study and Clinical Observation of Children With Crohn's Disease

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;

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Immunotherapy; Drug: biological agents; Drug: Glucocorticoids; Other: fecal microbiota transplantation; Drug: enteral nutrition

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Wuhan, China, 430030
    • Tongji Hospital, Wuhan, 430030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

100

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
enteral nutrition group; enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition	Drug: Immunotherapy; Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc; Other Names: immunosuppressor; Drug: biological agents; Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc; Other Names: biotherapy; Drug: Glucocorticoids; Glucocorticoids treatments are given; Other Names: glucocorticoid; Other: fecal microbiota transplantation; Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc; Other Names: Flora transplantation
Glucocorticoid group; Glucocorticoid therapy	Drug: biological agents; Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc; Other Names: biotherapy; Other: fecal microbiota transplantation; Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc; Other Names: Flora transplantation; Drug: enteral nutrition; exclusive enteral nutrition therapy or Partial enteral nutrition; Other Names: nutrition
Immunosuppressive group; Immunosuppressive therapy	Drug: biological agents; Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc; Other Names: biotherapy; Other: fecal microbiota transplantation; Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc; Other Names: Flora transplantation; Drug: enteral nutrition; exclusive enteral nutrition therapy or Partial enteral nutrition; Other Names: nutrition
Fecal Microbiota Transplantation group; Fecal Microbiota Transplantation therapy	Drug: Immunotherapy; Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc; Other Names: immunosuppressor; Drug: biological agents; Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc; Other Names: biotherapy; Drug: Glucocorticoids; Glucocorticoids treatments are given; Other Names: glucocorticoid; Drug: enteral nutrition; exclusive enteral nutrition therapy or Partial enteral nutrition; Other Names: nutrition
Biologics group; Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd).	Drug: Immunotherapy; Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc; Other Names: immunosuppressor; Drug: Glucocorticoids; Glucocorticoids treatments are given; Other Names: glucocorticoid; Other: fecal microbiota transplantation; Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc; Other Names: Flora transplantation; Drug: enteral nutrition; exclusive enteral nutrition therapy or Partial enteral nutrition; Other Names: nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings	14 weeks clinical response rate.	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission of different treatment regimens	Clinical remission rates at 14 and 54 weeks ( Pediatric Crohn's Disease Activity Index (PCDAI)≤10, PCDAI<10.0 was defined as the stage of clinical remission, 10.0~27.5 as the stage of clinical mild activity, 30.0~37.5 as the stage of clinical moderate activity, and 40.0~100.0 as the stage of clinical severe activity.)	14 and 54 weeks
Clinical response of different treatment regimens	Clinical response rate at 54 weeks (PCDAI reduction ≥15 points and total PCDAI≤30 points)	54 weeks
Endoscopic response of different treatment regimens	Endoscopic response rate at 14 and 54 weeks ((Simple Endoscopic Score for CD (SES-CD)≤2(the higher the score, the more severe the disease, heavy activity (SES-CD): >15 points) )	14 and 54 weeks
Mucosal healing of different treatment regimens	Mucosal healing rate at 14 and 54 weeks ((Simple Endoscopic Score for CD (SES-CD)=0 (the higher the score, the more severe the disease, heavy activity (SES-CD): >15 points) );	14 and 54 weeks
C-reactive protein of different treatment regimens	Changes of serum C-reactive protein from baseline at 14 and 54 weeks;	14 and 54 weeks
Erythrocyte sedimentation rate of different treatment regimens	Changes of serum erythrocyte sedimentation rate from baseline at 14 and 54 weeks;	14 and 54 weeks
Fecal calprotectin of different treatment regimens	Changes of serum fecal calprotectin from baseline at 14 and 54 weeks;	14 and 54 weeks
Intestinal flora of different treatment regimens	Changes in intestinal flora from baseline at 14 and 54 weeks; Fecal 16S rDNA or metagenome sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods	14 and 54 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness and safety	Record the incidence of adverse events/adverse reactions (observed at 102 weeks) after the first dose, accurately and specifically describe the incidence of adverse events (such as abdominal pain, fever, allergies, bloating, etc.).	102 weeks

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Director: Zhihua Huang Huang, Pro, Huazhong University of Science and Technology

Publications and helpful links

Helpful Links

• Mainly the incidence of IBD

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2028

Study Registration Dates

• First Submitted: October 26, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; Corticosteroids; immunosuppressants; biological agents;; Exclusive enteral nutrition
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Population Characteristics; Nutrition Therapy; Health Status; Demography; Adrenal Cortex Hormones; Immunomodulation; Feeding Methods; Nutritional Support; Glucocorticoids; Nutritional Status; Immunotherapy; Fecal Microbiota Transplantation; Biological Factors; Enteral Nutrition; macrophage-derived immunosuppressor factor; Biological Therapy
• Other Study ID Numbers: 63639582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Study Protocol has been uploaded ClinicalTrials.gov
• IPD Sharing Time Frame: 2024.10-2026.10
• IPD Sharing Access Criteria: Ipds can only be shared with the consent of the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No