Tongji Hospital, Wuhan, 430030
Wuhan, 430030, China
NCT Number: NCT06673134
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;
This study is active but is not currently recruiting participants.
Notify Me1 month–16 year
All sexes
Observational
Wuhan, 430030, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
exclusive enteral nutrition therapy or Partial enteral nutrition
Other names: nutrition
Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc
Other names: immunosuppressor
Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc
Other names: biotherapy
Glucocorticoids treatments are given
Other names: glucocorticoid
Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc
Other names: Flora transplantation
Time frame: 14 weeks
14 weeks clinical response rate.
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.)
Time frame: 54 weeks
Clinical response rate at 54 weeks (PCDAI reduction ≥15 points and total PCDAI≤30 points)
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) )
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) );
Time frame: 14 and 54 weeks
Changes of serum C-reactive protein from baseline at 14 and 54 weeks;
Time frame: 14 and 54 weeks
Changes of serum erythrocyte sedimentation rate from baseline at 14 and 54 weeks;
Time frame: 14 and 54 weeks
Changes of serum fecal calprotectin from baseline at 14 and 54 weeks;
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
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.).
Tongji Hospital
Other
Prospective Registry Study and Clinical Observation of Children With Crohn's Disease
Acronym: CD
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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