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

NCT03755583 | Completed

• 1 other identifier: IBD-EEN-microbiota
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Enteral Nutrition; Gastrointestinal Microbiome

Keywords

Exclusive enteral nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)

  0, 2, 6, 8, 12 weeks post-EEN

• 2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)

  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

Study Arms (1)

EEN group

OTHER

Received exclusive enteral nutrition after enrollment.

Dietary Supplement: Exclusive Enteral Nutrition

Interventions

Exclusive Enteral Nutrition DIETARY_SUPPLEMENT

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.

EEN group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of gastroenterology of Children's Hospital of Fudan University

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 28, 2018
• Study Start: February 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

CN (1)