Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Crohn Disease Clinical Trial

Official title:

Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502965
• Other study ID #: 2022-0454
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: huang xiaoxu
• Phone: +86-0571-87783851
• Email: xiaoxuhuang0909[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• dietary pattern
Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.
• EEN
All energy and nutrients are obtained from exclusive enteral nutrition.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dietary compliance	Modified medication adherence was measured, with < 6 points defined as low adherence, 6 to 8 points defined as moderate adherence, and > 8 points defined as high adherence	The two groups were evaluated at sixth week after surgery.
Primary	Quality of Life(IBDQ)	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.	The two groups of patients were scored at first week and sixth week after surgery.
Secondary	nutritional status of the patient	Body composition analysis, calf circumference in centimeter , albumin in g/L, hemoglobin in g/L, were measured to evaluate the nutritional status	The two groups were evaluated at first week and sixth week after surgery.
Secondary	Disease-related evaluation indicators	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.	The two groups were evaluated at first week and sixth week after surgery.