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

NCT06673134 | Active Not Recruiting

• 1 other identifier: 63639582
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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;

Conditions

Crohn Disease

Keywords

Corticosteroids; immunosuppressants; biological agents;; Exclusive enteral nutrition;; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical remission of different treatment regimens

  14 and 54 weeks

• Clinical response of different treatment regimens

  54 weeks

• Endoscopic response of different treatment regimens

  14 and 54 weeks

• Mucosal healing of different treatment regimens

  14 and 54 weeks

• C-reactive protein of different treatment regimens

  14 and 54 weeks

Other Outcomes (1)

• Effectiveness and safety

  102 weeks

Study Arms (5)

enteral nutrition group

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

Drug: Immunotherapy; Drug: biological agents; Drug: Glucocorticoids; Other: fecal microbiota transplantation

Glucocorticoid group

Glucocorticoid therapy

Drug: enteral nutrition; Drug: biological agents; Other: fecal microbiota transplantation

Immunosuppressive group

Immunosuppressive therapy

Drug: enteral nutrition; Drug: biological agents; Other: fecal microbiota transplantation

Fecal Microbiota Transplantation group

Fecal Microbiota Transplantation therapy

Drug: enteral nutrition; Drug: Immunotherapy; Drug: biological agents; Drug: Glucocorticoids

Biologics group

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

Drug: enteral nutrition; Drug: Immunotherapy; Drug: Glucocorticoids; Other: fecal microbiota transplantation

Interventions

enteral nutrition DRUG

exclusive enteral nutrition therapy or Partial enteral nutrition

Also known as: nutrition

Biologics group; Fecal Microbiota Transplantation group; Glucocorticoid group; Immunosuppressive group

Immunotherapy DRUG

Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc

Also known as: immunosuppressor

Biologics group; Fecal Microbiota Transplantation group; enteral nutrition group

biological agents DRUG

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

Also known as: biotherapy

Fecal Microbiota Transplantation group; Glucocorticoid group; Immunosuppressive group; enteral nutrition group

Glucocorticoids DRUG

Glucocorticoids treatments are given

Also known as: glucocorticoid

Biologics group; Fecal Microbiota Transplantation group; enteral nutrition group

fecal microbiota transplantation OTHER

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

Also known as: Flora transplantation

Biologics group; Glucocorticoid group; Immunosuppressive group; enteral nutrition group

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

100

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Wuhan, 430030

Wuhan, 430030, China

Location

Related Links

• Mainly the incidence of IBD

Biospecimen

Retention: SAMPLES WITH DNA

Serum specimen, Stool sample

MeSH Terms

Conditions

Crohn Disease

Interventions

Enteral Nutrition; Nutritional Status; Immunotherapy; macrophage-derived immunosuppressor factor; Biological Factors; Biological Therapy; Glucocorticoids; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Immunomodulation; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zhihua Huang Huang, Pro

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, pediatric department

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: November 4, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2024.10-2026.10
• Access Criteria: Ipds can only be shared with the consent of the principal investigator

Locations

CN (1)