Specific Dietary Pattern for Crohn's Disease Patients Following Surgery
Recruiting · NCT05502965 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
EENdietary pattern
What this trial is 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.
Who can take part
Age range
14 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University - Hangzhou, Zhejiang, China