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Recruiting NCT05502965

Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

No phase Interventional Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dietary pattern, EEN.
Who it may be relevant to
Registry conditions: Crohn Disease. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Quality of Life(IBDQ) [Time frame: The two groups of patients were scored at first week and sixth week after surgery.]
Secondary outcome measures (2)
  • nutritional status of the patient [Time frame: The two groups were evaluated at first week and sixth week after surgery.]
  • Disease-related evaluation indicators [Time frame: The two groups were evaluated at first week and sixth week after surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

China · 1 center
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT05502965 · 2022-0454

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗