Crohn Disease
Conditions
Keywords
Dietary Pattern, Crohn Disease
Brief summary
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
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.
Interventions
OTHERdietary pattern
Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.
OTHEREEN
All energy and nutrients are obtained from exclusive enteral nutrition.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnose CD according to endoscopy, histology and imaging; 2. Bowel resection for CD 3. Oral nutritional preparations or food can be given after surgery
Exclusion criteria
1. Plan operation within 5 weeks after surgery; 2. Presence of an ileostomy or colostomy 3. Complete bowel obstruction or fibrous stricture 4. Pregnancy or breastfeeding; 5. Plan to use biological agents within 5 weeks after surgery; 6. 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; 7. Plan to use probiotics or prebiotics for more than 1 week after surgery; 8. Antibiotics are used for more than 2 weeks after surgery; 9. Hypersensitivity to known components of enteral nutrition; 10. BMI less than 14 or greater than 28 kg/m2; 11. Celiac disease; 12. Complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis; 13. Mental illness; 14. Malignant tumors 15. Those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body) 16. Participating in other clinical trials 17. The researcher believes that others are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life(IBDQ) | The two groups of patients were scored at first week and sixth week after surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| nutritional status of the patient | The two groups were evaluated at first week and sixth week after surgery. | Body composition analysis, calf circumference in centimeter , albumin in g/L, hemoglobin in g/L, were measured to evaluate the nutritional status |
| Disease-related evaluation indicators | The two groups were evaluated at first week and sixth week after surgery. | 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. |
Countries
China
Contacts
CONTACThuang xiaoxu
CONTACTlu yanyu
PRINCIPAL_INVESTIGATORyu qiao
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
STUDY_DIRECTORguo huilan
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Outcome results
None listed