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

Inflammatory Bowel Diseases Clinical Trial

Official title:

Based on the Special Disease Management of Crohn's Disease Diet Studies --a Multicenter, Randomized, Controlled and Open Label Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976491
• Other study ID #: 2019-257
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qiao Yu, PhD
• Phone: 13456820567
• Email: yuqiao[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Dietary Supplement:
• CD-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
• EEN
EEN goup received EEN continuously for 6 moths

Locations

Country	Name	City	State
China	Second Affiliated Hospital Zhejiang University School of Medicine	Zhengzhou	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate of patients Maintain difference in remission rate	Clinical remission rate(Crohn's Disease Activity Index<150)	6 months
Secondary	Quality of life scale for IBD (inflammatory bowel disease) patients	Total score is 145, the higher scores mean a better outcome.	6 months