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Over the past 10 years, there are a large number of dietary treatments related to the CD, such as specific carbohydrate diet, low Fermentable Oligo-, Di-, Mono-saccharides And Polyols (FODMAP) diet, and allergen-free foods. But there is no consistent conclusion or convincing evidence about the effectiveness. Through the long-term clinical experience observation, we find most of the CD patients can get stable remission by removing refined food and intolerance food.This project aims at developing a new dietary therapy suitable for Chinese patients.
The dietary therapy is based on the nutrient composition of exclusive enteral nutrition and is more in line with Chinese patients' dietary habits and economic conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive Enteral Nutrition(EEN) | Active Comparator | Subjects required exclusive enteral nutrition for one month |
|
| Specific Diet+ Partial Enteral Nutrition | Experimental | Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary pattern | Other | Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life(IBDQ) | IBDQ: Inflammatory Bowel Disease Questionnaire.The IBDQ evaluates the quality of life of patients from four aspects: intestinal symptoms, systemic symptoms, emotional function and social function. There are 32 questions in the questionnaire, with a total score of 32 to 224 points. The higher the score, the higher the quality of life of the patient. | The two groups of patients were scored at first week and sixth week after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| nutritional status of the patient | Body composition analysis, calf circumference in centimeter , albumin in g/L, hemoglobin in g/L, were measured to evaluate the nutritional status | The two groups were evaluated at first week and sixth week after surgery. |
| Disease-related evaluation indicators |
| Measure | Description | Time Frame |
|---|---|---|
| dietary compliance | Modified medication adherence was measured, with < 6 points defined as low adherence, 6 to 8 points defined as moderate adherence, and > 8 points defined as high adherence | The two groups were evaluated at sixth week after surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| huang xiaoxu | Contact | +86-0571-87783851 | xiaoxuhuang0909@126.com | |
| lu yanyu | Contact | +86-0571-87783851 | luyanyu@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| yu qiao | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| guo huilan | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000095362 | Dietary Patterns |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| EEN | Other | All energy and nutrients are obtained from exclusive enteral nutrition. |
|
We assessed the effect of the intervention on disease by measuring the following indicators: Harvey-Bradshaw Index(HBI), Crohn's Disease Activity Index (CDAI), C Reactive Protein (CRP)in mg/L, Erythrocyte Sedimentation Rate (ESR) in mm/h, platelets in 10^9/L, triglycerides in m mol/L, cholesterol in m mol/L , uric acid in u mol/L. |
| The two groups were evaluated at first week and sixth week after surgery. |
| D007410 | Intestinal Diseases |
| D005247 | Feeding Behavior |