Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05502965
• Collaborator: (none)
• Enrollment: 35
• Arms: 2
• Anticipated Duration (Months): 21.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Other: dietary pattern; Other: EEN	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exclusive Enteral Nutrition(EEN) Subjects required exclusive enteral nutrition for one month	Other: EEN; All energy and nutrients are obtained from exclusive enteral nutrition.
Experimental: Specific Diet+ Partial Enteral Nutrition Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month	Other: dietary pattern; Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.; Other Names: dietary guidance

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

Other Outcome Measures

1. dietary compliance [The two groups were evaluated at sixth week after surgery.]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Principal Investigator: yu qiao, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study Director: guo huilan, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05502965
• Other Study ID Numbers: 2022-0454
• First Posted: Aug 16, 2022
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: Dietary Pattern, Crohn Disease
• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Aug 16, 2022