Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Not Applicable

• Conditions: Crohn Disease
• Interventions: Other: EEN; Other: dietary pattern

• Registration Number: NCT05502965
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-14
• Study First Posted: 2022-08-16
• Study Start: 2022-09-17
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exclusive Enteral Nutrition(EEN)	EEN	Subjects required exclusive enteral nutrition for one month
Specific Diet+ Partial Enteral Nutrition	dietary pattern	Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China