Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Zhejiang University

Status: Enrolling

Conditions: Crohn Disease

Treatments: Other: EEN; Other: dietary pattern

Study type: Interventional

Funder types: Other

Identifiers

NCT05502965

2022-0454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Exclusive Enteral Nutrition(EEN)

Active Comparator group

Description:

Subjects required exclusive enteral nutrition for one month

Treatment:

Other: EEN

Specific Diet+ Partial Enteral Nutrition

Experimental group

Description:

Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month

Treatment:

Other: dietary pattern