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Status unknownNCT04976491Updated Dec 22, 2021

Based on the Special Disease Management of Crohn's Disease Diet Studies

An observational study in Inflammatory Bowel Diseases, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-22.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
5
Ages
6 Years to 15 Years
Sex
All
01

Study summary

This project plans to develop a new diet therapy suitable for China -- CD-C-food, which is more in line with the common diet of Chinese patients' eating habits and economic conditions, and its expected therapeutic effect and influence on intestinal microorganism are similar to that of EEN. In order to explore the influence of intestinal microorganisms and their metabolites on the clinical remission effect and inflammatory response of patients with CD-C-Food, and to reveal the possible internal mechanism, a randomized control of adult subjects with a healthy CD-Chinese-food diet, treatment group of CD patients and animal model will be conducted by using intestinal microbiome, bacterial metabolite analysis, inflammatory factors detection and other technical means.

Read the detailed description

Exclusive Enteral Nutrition (EEN) is the only established dietary treatment for children with CD.Changes in diet affect the amount of short-chain fatty acids and branched-chain fatty acids produced by changing the composition of intestinal flora, leading to changes in intestinal state.Through the long-term clinical observation of our team, most patients with CD can achieve stable remission by removing the processed food and screening the corresponding food by combining the characteristics of Chinese diet with the food intolerance detection method. So, what kind of diet is suitable for the treatment of CD patients in China? The CD-Treat program, replacing the Western diet with Chinese diet, so as to design an individualized program CD-Chinese-food (CD-C-food) that is consistent with the eating habits of Chinese patients with CD. By comparing the effects of this individualized diet with EEN on inducing and maintaining remission in CD patients.

02

Conditions studied

  • Inflammatory Bowel Diseases
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 5 is below the median of 162 across 608 observational 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.

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Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The trial was carried out in 6 IBD center hospitals in China. The heads of IBD centers in all hospitals are members of the CCCF Academic Committee. A total of 200 IBD cases are planned to be enrolled in 6 centers.

Inclusion criteria

  1. patients who are clinically diagnosed as stable CD; the diagnosis of CD has evidence of clinical manifestations and endoscopy, and was confirmed by histopathological report, referring to the consensus opinion on the diagnosis and treatment of inflammatory bowel disease in 2018. CDAI (Crohn's disease activity index)\<150 points is regarded as clinical remission.
  2. Have reading ability, can access the Internet, use mobile phone WeChat and use application (APP) software with the assistance of oneself or family members;

Exclusion criteria

Exclusion Criteria:

  1. Active patients (referring to CDAI greater than 150);
  2. CD patients who currently need or expect surgical intervention during the study period.
  3. CD patients with symptoms or signs of perforation such as abdominal abscess, intestinal fistula, etc.
  4. Patients with complete intestinal obstruction or fibrous stenosis with pre-stenosis dilation that require surgery to relieve the obstruction.
  5. CD patients with colorectal tumors. Those who have EN contraindications (active gastrointestinal bleeding, severe esophageal and gastric varices, intestinal obstruction, abdominal cavity syndrome, etc.).
  6. Pregnancy and breastfeeding patients.
  7. Severe hemodynamics, unstable vital signs, or the presence of rapid progression or end-stage disease, are expected to die during the course of the study.
  8. Patients diagnosed with short bowel syndrome or with ileostomy or colostomy.
  9. Patients with severe liver and kidney dysfunction, active infection, or other reasons (such as previous infliximab anaphylactic shock) cannot tolerate the treatment drugs used in this study.
  10. The patient is allergic to known ingredients of enteral nutrition or has no previous EEN for 12 weeks.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
5 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • CD-C-Food group

    During the first 3 months,participants received EEN;In the second 3months , CD-C-Food group received received CD-C-food .

    Dietary Supplement: CD-C-Food

  • EEN group

    During the period, participants received EEN for 6 months.

    Dietary Supplement: EEN

Interventions

  • Dietary supplementCD-C-Food

    CD patients combined with the characteristics of Chinese diet, remove the refined food, and combined with food intolerance detection method to check the corresponding food

  • Dietary supplementEEN

    EEN goup received EEN continuously for 6 moths

06

What researchers measure

Primary outcomes

  1. Remission rate of patients Maintain difference in remission rate

    Clinical remission rate(Crohn's Disease Activity Index\<150)

    Time frame: 6 months

Secondary outcomes

  1. Quality of life scale for IBD (inflammatory bowel disease) patients

    Total score is 145, the higher scores mean a better outcome.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital Zhejiang University School of Medicine
    Zhengzhou, Hangzhou 310000, China
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 1, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04976491
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
Aug 1, 2020
Primary completion
Aug 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Dec 22, 2021

Study contacts

Qiao Yu, PhD
Contact
yuqiao@zju.edu.cn
13456820567

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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