Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755583
• Other study ID #: IBD-EEN-microbiota
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve nutritional status and inflammatory markers in pediatric CD. But there is limited data about the effect of EEN on Chinese children with CD. In this study, investigators focused on disease process,nutritional status and gut microbiome of Chinese children with newly-diagnosed CD after EEN treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• Pediatric CD patients who were newly diagnosed and being treated with EEN at the Children's Hospital of Fudan University

Exclusion Criteria:

• (1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the EEN process.

Related Conditions & MeSH terms

• Crohn Disease
• Enteral Nutrition
• Gastrointestinal Microbiome

Intervention

Dietary Supplement:
• Exclusive Enteral Nutrition
a complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament.

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-item gut microbiota measure	the change of gut microbiota during EEN and after the end of EEN	0, 2, 6, 8, 12 weeks post-EEN
Primary	2-item Simple Endoscopic Score for CD (SES-CD)	According to the SES-CD, at the end of EEN, the patients whose SES-CD scores were =4 were classified into the remission group (CD-RE), other patients whose SES-CD scores were >4 were classified into the non-remission group (CD-NRE)	0, 8, weeks post-EEN
Secondary	5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)	wPCDAI scoret included 8 items (Abdominal pain, Patient functioning, Stools, ESR, Albumin, Weight, Perirectal disease, Extraintestinal manifestations ).	0, 2, 6, 8, 12 weeks post-EEN
Secondary	2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)	the level of 25-OH VITD3 in 8 weeks post-EEN is higher than 0 week represents a better outcome	0,8 weeks post-EEN
Secondary	5-item weight measure		0, 2, 6, 8, 12 weeks post-EEN
Secondary	5-item height measure		0, 2, 6, 8, 12 weeks post-EEN
Secondary	5-item Fecal Calprotectin		0, 2, 6, 8, 12 weeks post-EEN
Secondary	2-item Insulin-like growth factor-1		0, 8 weeks post-EEN
Secondary	2-item Calcium, vitamin		0, 8 weeks post-EEN