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NCT Number: NCT06673134

Prospective Cohort Establishment 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;

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This study is active but is not currently recruiting participants.

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Key information

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Wuhan, 430030

Wuhan, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

enteral nutrition

Drug

exclusive enteral nutrition therapy or Partial enteral nutrition

Other names: nutrition

Immunotherapy

Drug

Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc

Other names: immunosuppressor

biological agents

Drug

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

Other names: biotherapy

Glucocorticoids

Drug

Glucocorticoids treatments are given

Other names: glucocorticoid

Fecal microbiota transplantation

Other

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

Other names: Flora transplantation

Primary outcomes

  1. To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings

    Time frame: 14 weeks

    14 weeks clinical response rate.

Secondary outcomes

  1. Clinical remission of different treatment regimens

    Time frame: 14 and 54 weeks

    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.)

  2. Clinical response of different treatment regimens

    Time frame: 54 weeks

    Clinical response rate at 54 weeks (PCDAI reduction ≥15 points and total PCDAI≤30 points)

  3. Endoscopic response of different treatment regimens

    Time frame: 14 and 54 weeks

    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) )

  4. Mucosal healing of different treatment regimens

    Time frame: 14 and 54 weeks

    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) );

  5. C-reactive protein of different treatment regimens

    Time frame: 14 and 54 weeks

    Changes of serum C-reactive protein from baseline at 14 and 54 weeks;

  6. Erythrocyte sedimentation rate of different treatment regimens

    Time frame: 14 and 54 weeks

    Changes of serum erythrocyte sedimentation rate from baseline at 14 and 54 weeks;

  7. Fecal calprotectin of different treatment regimens

    Time frame: 14 and 54 weeks

    Changes of serum fecal calprotectin from baseline at 14 and 54 weeks;

  8. Intestinal flora of different treatment regimens

    Time frame: 14 and 54 weeks

    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

Other outcomes

  1. Effectiveness and safety

    Time frame: 102 weeks

    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.).

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Acronym: CD

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Nov 4, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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