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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Enteral Nutrition; Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Exclusive Enteral Nutrition

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EEN group; Received exclusive enteral nutrition after enrollment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
5-item weight measure		0, 2, 6, 8, 12 weeks post-EEN
5-item height measure		0, 2, 6, 8, 12 weeks post-EEN
5-item Fecal Calprotectin		0, 2, 6, 8, 12 weeks post-EEN
2-item Insulin-like growth factor-1		0, 8 weeks post-EEN
2-item Calcium, vitamin		0, 8 weeks post-EEN

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 24, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exclusive enteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: IBD-EEN-microbiota

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No