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

NCT04976491 | Unknown DMC

• 1 other identifier: 2019-257
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Remission rate of patients Maintain difference in remission rate

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

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

CD-C-Food DIETARY_SUPPLEMENT

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

CD-C-Food group

EEN DIETARY_SUPPLEMENT

EEN goup received EEN continuously for 6 moths

EEN group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.
• Have reading ability, can access the Internet, use mobile phone WeChat and use application (APP) software with the assistance of oneself or family members;

You may not qualify if:

• Active patients (referring to CDAI greater than 150);
• CD patients who currently need or expect surgical intervention during the study period.
• CD patients with symptoms or signs of perforation such as abdominal abscess, intestinal fistula, etc.
• Patients with complete intestinal obstruction or fibrous stenosis with pre-stenosis dilation that require surgery to relieve the obstruction.
• CD patients with colorectal tumors. Those who have EN contraindications (active gastrointestinal bleeding, severe esophageal and gastric varices, intestinal obstruction, abdominal cavity syndrome, etc.).
• Pregnancy and breastfeeding patients.
• 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.
• Patients diagnosed with short bowel syndrome or with ileostomy or colostomy.
• 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.
• The patient is allergic to known ingredients of enteral nutrition or has no previous EEN for 12 weeks.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Zhengzhou, Hangzhou, 310000, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Qiao Yu, PhD

CONTACT

13456820567; yuqiao@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: July 26, 2021
• Study Start: August 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 22, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)