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NCT Number: NCT05502965

Specific Dietary Pattern for Crohn's Disease 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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

huang xiaoxu

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dietary pattern

Other

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

Other names: dietary guidance

EEN

Other

All energy and nutrients are obtained from exclusive enteral nutrition.

Primary outcomes

  1. Quality of Life(IBDQ)

    Time frame: 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 outcomes

  1. nutritional status of the patient

    Time frame: 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

    Time frame: 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 outcomes

  1. dietary compliance

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

huang xiaoxu

CONTACT

[email protected]

+86-0571-87783851

lu yanyu

CONTACT

[email protected]

+86-0571-87783851

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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