Studies
| Study First Submitted Date | 2021-08-05 |
| Study First Posted Date | 2021-08-10 |
| Last Update Posted Date | 2023-07-05 |
| Start Month Year | March 1, 2024 |
| Primary Completion Month Year | October 1, 2024 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-05 |
Detailed Descriptions
| Sequence: | 20712263 |
| Description | The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated. |
Browse Interventions
| Sequence: | 96007687 | Sequence: | 96007688 | Sequence: | 96007689 | Sequence: | 96007690 | Sequence: | 96007691 | Sequence: | 96007692 | Sequence: | 96007693 | Sequence: | 96007694 | Sequence: | 96007695 | Sequence: | 96007696 | Sequence: | 96007697 | Sequence: | 96007698 | Sequence: | 96007699 |
| Mesh Term | Infliximab | Mesh Term | Mesalamine | Mesh Term | Tumor Necrosis Factor Inhibitors | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Dermatologic Agents | Mesh Term | Gastrointestinal Agents | Mesh Term | Antirheumatic Agents | Mesh Term | Anti-Inflammatory Agents, Non-Steroidal | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs |
| Downcase Mesh Term | infliximab | Downcase Mesh Term | mesalamine | Downcase Mesh Term | tumor necrosis factor inhibitors | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | dermatologic agents | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | anti-inflammatory agents, non-steroidal | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52145132 | Sequence: | 52145133 | Sequence: | 52145134 |
| Name | Exclusive Enteral Nutrition | Name | Ulcerative Colitis | Name | Children |
| Downcase Name | exclusive enteral nutrition | Downcase Name | ulcerative colitis | Downcase Name | children |
Id Information
| Sequence: | 40139508 |
| Id Source | org_study_id |
| Id Value | UC1.2 |
Design Groups
| Sequence: | 55566026 | Sequence: | 55566027 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | EEN combined therapy group | Title | Non EEN combination group |
| Description | in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab | Description | in the induction of remission phase, corticosteroids or infliximab will be used without EEN |
Interventions
| Sequence: | 52460986 | Sequence: | 52460987 |
| Intervention Type | Combination Product | Intervention Type | Combination Product |
| Name | exclusive enteral nutrition | Name | regular food |
| Description | Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food. | Description | Administration of regular food in the induction phase and the later time. |
Design Outcomes
| Sequence: | 177289172 | Sequence: | 177289173 | Sequence: | 177289174 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | The mucosal healing rate | Measure | sustained corticosteroid-free clinical remission rate | Measure | Treatment modification rate |
| Time Frame | 12 week after intervention | Time Frame | 1 year after intervention | Time Frame | 1 year after intervention |
| Description | The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist. | Description | Sustained pediatric Ulcerative Colitis activity index (PUCAI) score <10 points during follow-up (week 14 to week 54 after intervention) without the treatment of corticosteroids . This will be evaluated by gastroenterologist. | Description | The rate of new treatment measures needed to be started due to worsening of symptoms. |
Browse Conditions
| Sequence: | 193389562 | Sequence: | 193389563 | Sequence: | 193389564 | Sequence: | 193389565 | Sequence: | 193389566 | Sequence: | 193389567 | Sequence: | 193389568 | Sequence: | 193389569 | Sequence: | 193389570 | Sequence: | 193389571 |
| Mesh Term | Colitis | Mesh Term | Colitis, Ulcerative | Mesh Term | Ulcer | Mesh Term | Gastroenteritis | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Pathologic Processes | Mesh Term | Inflammatory Bowel Diseases |
| Downcase Mesh Term | colitis | Downcase Mesh Term | colitis, ulcerative | Downcase Mesh Term | ulcer | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | inflammatory bowel diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48296118 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Children's Hospital of Fudan University |
Overall Officials
| Sequence: | 29271611 |
| Role | Study Director |
| Name | Ying Huang |
| Affiliation | Children's Hospital of Fudan University |
Central Contacts
| Sequence: | 12002513 |
| Contact Type | primary |
| Name | Cui fang Zheng |
| Phone | 8615221881022 |
| zhengcuifang2@126.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68115950 | Sequence: | 68115951 |
| Design Group Id | 55566026 | Design Group Id | 55566027 |
| Intervention Id | 52460986 | Intervention Id | 52460987 |
Eligibilities
| Sequence: | 30751120 |
| Gender | All |
| Minimum Age | 6 Years |
| Maximum Age | 18 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Newly diagnosed UC Years 6 to 18 Moderate to severe disease activity at diagnosis Exclusion Criteria: With mild disease activity at diagnosis Had been treated with corticosteroids or biologics |
| Adult | True |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 254156605 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 6 |
| Maximum Age Num | 18 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30497394 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Single |
| Outcomes Assessor Masked | True |
Intervention Other Names
| Sequence: | 26658936 | Sequence: | 26658937 |
| Intervention Id | 52460986 | Intervention Id | 52460987 |
| Name | corticosteroids, infliximab, 5-ASA, AZA | Name | corticosteroids, infliximab, 5-ASA, AZA |
Responsible Parties
| Sequence: | 28863667 |
| Responsible Party Type | Principal Investigator |
| Name | Ying HUANG |
| Title | Chief of Gastroenterology |
| Affiliation | Children's Hospital of Fudan University |