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This project plans to develop a new diet therapy suitable for China -- CD-C-food, which is more in line with the common diet of Chinese patients' eating habits and economic conditions, and its expected therapeutic effect and influence on intestinal microorganism are similar to that of EEN. In order to explore the influence of intestinal microorganisms and their metabolites on the clinical remission effect and inflammatory response of patients with CD-C-Food, and to reveal the possible internal mechanism, a randomized control of adult subjects with a healthy CD-Chinese-food diet, treatment group of CD patients and animal model will be conducted by using intestinal microbiome, bacterial metabolite analysis, inflammatory factors detection and other technical means.
Exclusive Enteral Nutrition (EEN) is the only established dietary treatment for children with CD.Changes in diet affect the amount of short-chain fatty acids and branched-chain fatty acids produced by changing the composition of intestinal flora, leading to changes in intestinal state.Through the long-term clinical observation of our team, most patients with CD can achieve stable remission by removing the processed food and screening the corresponding food by combining the characteristics of Chinese diet with the food intolerance detection method. So, what kind of diet is suitable for the treatment of CD patients in China? The CD-Treat program, replacing the Western diet with Chinese diet, so as to design an individualized program CD-Chinese-food (CD-C-food) that is consistent with the eating habits of Chinese patients with CD. By comparing the effects of this individualized diet with EEN on inducing and maintaining remission in CD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD-C-Food group | During the first 3 months,participants received EEN;In the second 3months , CD-C-Food group received received CD-C-food . |
| |
| EEN group | During the period, participants received EEN for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD-C-Food | Dietary Supplement | CD patients combined with the characteristics of Chinese diet, remove the refined food, and combined with food intolerance detection method to check the corresponding food |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of patients Maintain difference in remission rate | Clinical remission rate(Crohn's Disease Activity Index<150) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life scale for IBD (inflammatory bowel disease) patients | Total score is 145, the higher scores mean a better outcome. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The trial was carried out in 6 IBD center hospitals in China. The heads of IBD centers in all hospitals are members of the CCCF Academic Committee. A total of 200 IBD cases are planned to be enrolled in 6 centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiao Yu, PhD | Contact | 13456820567 | yuqiao@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Zhengzhou | Hangzhou | 310000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2021 | Nov 24, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| EEN | Dietary Supplement | EEN goup received EEN continuously for 6 moths |
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