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RecruitingNCT05502965Updated Feb 2, 2026

Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

An interventional study of dietary pattern and EEN in Crohn Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Crohn Disease

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Keywords

  • Dietary Pattern, Crohn Disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 35 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Active comparator
    Exclusive Enteral Nutrition(EEN)

    Subjects required exclusive enteral nutrition for one month

    Other: EEN

  • 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

Interventions

  • Otherdietary pattern

    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

  • OtherEEN

    All energy and nutrients are obtained from exclusive enteral nutrition.

06

What researchers measure

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.

    Time frame: The two groups of patients were scored at first week and sixth week after surgery.

Secondary outcomes

  1. 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

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

  2. 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.

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

Other outcomes

  1. 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

    Time frame: The two groups were evaluated at sixth week after surgery.

07

Study locations

1 of 1 sites recruiting
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    • huang xiaoxu · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05502965
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Aug 16, 2022
Start date
Sep 17, 2022
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Feb 2, 2026

Study contacts

huang xiaoxu
Contact
xiaoxuhuang0909@126.com
+86-0571-87783851
lu yanyu
Contact
luyanyu@zju.edu.cn
+86-0571-87783851
yu qiao
principal investigator · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
guo huilan
study director · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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