Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: dietary pattern
* Other: EEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnose CD according to endoscopy, histology and imaging; Bowel resection for CD Oral nutritional preparations or food can be given after surgery Exclusion Criteria: Plan operation within 5 weeks after surgery; Presence of an ileostomy or colostomy Complete bowel obstruction or fibrous stricture Pregnancy or breastfeeding; Plan to use biological agents within 5 weeks after surgery; Plan to use corticosteroids or prednisone greater than 20 mg per day or equivalent doses of drugs to maintain remission within 5 weeks after surgery; Plan to use probiotics or prebiotics for more than 1 week after surgery; Antibiotics are used for more than 2 weeks after surgery; Hypersensitivity to known components of enteral nutrition; BMI less than 14 or greater than 28 kg/m2; Celiac disease; Complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis; Mental illness; Malignant tumors Those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body) Participating in other clinical trials The researcher believes that others are not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exclusive Enteral Nutrition(EEN)<br>Subjects required exclusive enteral nutrition for one month | Other: EEN<br>* All energy and nutrients are obtained from exclusive enteral nutrition.<br>|
| Experimental: Specific Diet+ Partial Enteral Nutrition<br>Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month | Other: dietary pattern<br>* Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.<br>* Other names: dietary guidance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Pattern, Crohn Disease