Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT06673134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}, {'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'C046429', 'term': 'macrophage-derived immunosuppressor factor'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D005938', 'term': 'Glucocorticoids'}, {'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-24', 'size': 121606, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-29T09:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum specimen, Stool sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-07-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-10-26', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effectiveness and safety', 'timeFrame': '102 weeks', 'description': '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.).'}], 'primaryOutcomes': [{'measure': "To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings", 'timeFrame': '14 weeks', 'description': '14 weeks clinical response rate.'}], 'secondaryOutcomes': [{'measure': 'Clinical remission of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': "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.)"}, {'measure': 'Clinical response of different treatment regimens', 'timeFrame': '54 weeks', 'description': 'Clinical response rate at 54 weeks (PCDAI reduction ≥15 points and total PCDAI≤30 points)'}, {'measure': 'Endoscopic response of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': '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) )'}, {'measure': 'Mucosal healing of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': '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) );'}, {'measure': 'C-reactive protein of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': 'Changes of serum C-reactive protein from baseline at 14 and 54 weeks;'}, {'measure': 'Erythrocyte sedimentation rate of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': 'Changes of serum erythrocyte sedimentation rate from baseline at 14 and 54 weeks;'}, {'measure': 'Fecal calprotectin of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': 'Changes of serum fecal calprotectin from baseline at 14 and 54 weeks;'}, {'measure': 'Intestinal flora of different treatment regimens', 'timeFrame': '14 and 54 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corticosteroids', 'immunosuppressants', 'biological agents;', 'Exclusive enteral nutrition;', 'pediatric'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pm.yuntsg.com/details.html?pmid=29050646&key=Ng%20SC,%20Shi%20HY,%20Hamidi%20N,%20et%20al.%20worldwide%20incidence%20and%20prevalence%20of%20inflammatory%20bowel%20disease%20in%20the%2021st%20century:%20a%20systematic%20review%20of%20population-based%20studies.%20Lancet.', 'label': 'Mainly the incidence of IBD'}]}, 'descriptionModule': {'briefSummary': "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;", 'detailedDescription': "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.\n\nDynamic 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children under 17 years old;\n* Children with a definite diagnosis of Crohn's disease;\n* Patients and their guardians must sign informed consent;\n\nExclusion Criteria:\n\n* Other conditions deemed inappropriate by the doctor to participate in the study;"}, 'identificationModule': {'nctId': 'NCT06673134', 'acronym': 'CD', 'briefTitle': "Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': "Prospective Registry Study and Clinical Observation of Children With Crohn's Disease", 'orgStudyIdInfo': {'id': '63639582'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'enteral nutrition group', 'description': 'enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition', 'interventionNames': ['Drug: Immunotherapy', 'Drug: biological agents', 'Drug: Glucocorticoids', 'Other: fecal microbiota transplantation']}, {'label': 'Glucocorticoid group', 'description': 'Glucocorticoid therapy', 'interventionNames': ['Drug: enteral nutrition', 'Drug: biological agents', 'Other: fecal microbiota transplantation']}, {'label': 'Immunosuppressive group', 'description': 'Immunosuppressive therapy', 'interventionNames': ['Drug: enteral nutrition', 'Drug: biological agents', 'Other: fecal microbiota transplantation']}, {'label': 'Fecal Microbiota Transplantation group', 'description': 'Fecal Microbiota Transplantation therapy', 'interventionNames': ['Drug: enteral nutrition', 'Drug: Immunotherapy', 'Drug: biological agents', 'Drug: Glucocorticoids']}, {'label': 'Biologics group', 'description': 'Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd).', 'interventionNames': ['Drug: enteral nutrition', 'Drug: Immunotherapy', 'Drug: Glucocorticoids', 'Other: fecal microbiota transplantation']}], 'interventions': [{'name': 'enteral nutrition', 'type': 'DRUG', 'otherNames': ['nutrition'], 'description': 'exclusive enteral nutrition therapy or Partial enteral nutrition', 'armGroupLabels': ['Biologics group', 'Fecal Microbiota Transplantation group', 'Glucocorticoid group', 'Immunosuppressive group']}, {'name': 'Immunotherapy', 'type': 'DRUG', 'otherNames': ['immunosuppressor'], 'description': 'Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc', 'armGroupLabels': ['Biologics group', 'Fecal Microbiota Transplantation group', 'enteral nutrition group']}, {'name': 'biological agents', 'type': 'DRUG', 'otherNames': ['biotherapy'], 'description': 'Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc', 'armGroupLabels': ['Fecal Microbiota Transplantation group', 'Glucocorticoid group', 'Immunosuppressive group', 'enteral nutrition group']}, {'name': 'Glucocorticoids', 'type': 'DRUG', 'otherNames': ['glucocorticoid'], 'description': 'Glucocorticoids treatments are given', 'armGroupLabels': ['Biologics group', 'Fecal Microbiota Transplantation group', 'enteral nutrition group']}, {'name': 'fecal microbiota transplantation', 'type': 'OTHER', 'otherNames': ['Flora transplantation'], 'description': 'Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc', 'armGroupLabels': ['Biologics group', 'Glucocorticoid group', 'Immunosuppressive group', 'enteral nutrition group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Hospital, Wuhan, 430030', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Zhihua Huang Huang, Pro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2024.10-2026.10', 'ipdSharing': 'YES', 'description': 'The Study Protocol has been uploaded ClinicalTrials.gov', 'accessCriteria': 'Ipds can only be shared with the consent of the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician, pediatric department', 'investigatorFullName': 'Biao Zou', 'investigatorAffiliation': 'Tongji Hospital'}}}}