Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: EEN; Other: dietary pattern

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: huang xiaoxu; Phone Number: +86-0571-87783851; Email: xiaoxuhuang0909@126.com
• Study Contact Backup: Name: lu yanyu; Phone Number: +86-0571-87783851; Email: luyanyu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: huang xiaoxu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): September 17, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dietary Pattern, Crohn Disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet; Feeding Behavior; Dietary Patterns
• Other Study ID Numbers: 2022-0454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No