Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
- Conditions
- Crohn Disease
- Interventions
- Drug: enteral nutritionDrug: ImmunotherapyDrug: biological agentsOther: fecal microbiota transplantationDrug: Glucocorticoids
- Registration Number
- NCT06673134
- Lead Sponsor
- Tongji Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Children under 17 years old;
- Children with a definite diagnosis of Crohn's disease;
- Patients and their guardians must sign informed consent;
- Other conditions deemed inappropriate by the doctor to participate in the study;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fecal Microbiota Transplantation group biological agents Fecal Microbiota Transplantation therapy Fecal Microbiota Transplantation group Glucocorticoids Fecal Microbiota Transplantation therapy Immunosuppressive group fecal microbiota transplantation Immunosuppressive therapy Fecal Microbiota Transplantation group enteral nutrition Fecal Microbiota Transplantation therapy enteral nutrition group Immunotherapy enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition enteral nutrition group biological agents enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition enteral nutrition group Glucocorticoids enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition enteral nutrition group fecal microbiota transplantation enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition Glucocorticoid group enteral nutrition Glucocorticoid therapy Glucocorticoid group biological agents Glucocorticoid therapy Glucocorticoid group fecal microbiota transplantation Glucocorticoid therapy Immunosuppressive group enteral nutrition Immunosuppressive therapy Immunosuppressive group biological agents Immunosuppressive therapy Fecal Microbiota Transplantation group Immunotherapy Fecal Microbiota Transplantation therapy Biologics group enteral nutrition Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd). Biologics group Immunotherapy Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd). Biologics group Glucocorticoids Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd). Biologics group fecal microbiota transplantation Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd).
- Primary Outcome Measures
Name Time Method To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings 14 weeks 14 weeks clinical response rate.
- Secondary Outcome Measures
Name Time Method Erythrocyte sedimentation rate of different treatment regimens 14 and 54 weeks Changes of serum erythrocyte sedimentation rate from baseline at 14 and 54 weeks;
Fecal calprotectin of different treatment regimens 14 and 54 weeks Changes of serum fecal calprotectin from baseline at 14 and 54 weeks;
Intestinal flora of different treatment regimens 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
C-reactive protein of different treatment regimens 14 and 54 weeks Changes of serum C-reactive protein from baseline at 14 and 54 weeks;
Endoscopic response of different treatment regimens 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) )
Mucosal healing of different treatment regimens 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) );
Clinical remission of different treatment regimens 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.)
Clinical response of different treatment regimens 54 weeks Clinical response rate at 54 weeks (PCDAI reduction ≥15 points and total PCDAI≤30 points)
Trial Locations
- Locations (1)
Tongji Hospital, Wuhan, 430030
🇨🇳Wuhan,, China