Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-17

Study Completion Date

2024-06-30

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.

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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.

Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Exclusive Enteral Nutrition(EEN)

Subjects required exclusive enteral nutrition for one month

Group Type ACTIVE_COMPARATOR

EEN

Intervention Type OTHER

All energy and nutrients are obtained from exclusive enteral nutrition.

Specific Diet+ Partial Enteral Nutrition

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

Group Type EXPERIMENTAL

dietary pattern

Intervention Type OTHER

Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.

Interventions

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dietary pattern

Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.

Intervention Type OTHER

EEN

All energy and nutrients are obtained from exclusive enteral nutrition.

Intervention Type OTHER

Other Intervention Names

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dietary guidance

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No