Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

NCT05502965 | Recruiting

• 1 other identifier: 2022-0454
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Dietary Pattern, Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• nutritional status of the patient

  The two groups were evaluated at first week and sixth week after surgery.

• Disease-related evaluation indicators

  The two groups were evaluated at first week and sixth week after surgery.

Other Outcomes (1)

• dietary compliance

  The two groups were evaluated at sixth week after surgery.

Study Arms (2)

Exclusive Enteral Nutrition(EEN)

ACTIVE COMPARATOR

Subjects required exclusive enteral nutrition for one month

Other: EEN

Specific Diet+ Partial Enteral Nutrition

EXPERIMENTAL

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

Other: dietary pattern

Interventions

dietary pattern OTHER

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

Also known as: dietary guidance

Specific Diet+ Partial Enteral Nutrition

EEN OTHER

All energy and nutrients are obtained from exclusive enteral nutrition.

Exclusive Enteral Nutrition(EEN)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnose CD according to endoscopy, histology and imaging;
• Bowel resection for CD
• Oral nutritional preparations or food can be given after surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Dietary Patterns

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Feeding Behavior

Study Officials

• yu qiao

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

• guo huilan

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY DIRECTOR

Central Study Contacts

huang xiaoxu

CONTACT

+86-0571-87783851; xiaoxuhuang0909@126.com

lu yanyu

CONTACT

+86-0571-87783851; luyanyu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 16, 2022
• Study Start: September 17, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)