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

Primary Purpose

Crohn Disease, Enteral Nutrition, Gastrointestinal Microbiome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exclusive Enteral Nutrition
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Exclusive enteral nutrition

Eligibility Criteria

1 Year - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's hospital of Fudan university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EEN group

Arm Description

Received exclusive enteral nutrition after enrollment.

Outcomes

Primary Outcome Measures

5-item gut microbiota measure
the change of gut microbiota during EEN and after the end of 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)

Secondary Outcome Measures

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 ).
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
5-item weight measure
5-item height measure
5-item Fecal Calprotectin
2-item Insulin-like growth factor-1
2-item Calcium, vitamin

Full Information

First Posted
November 18, 2018
Last Updated
January 23, 2020
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03755583
Brief Title
Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease
Official Title
Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Enteral Nutrition, Gastrointestinal Microbiome
Keywords
Exclusive enteral nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EEN group
Arm Type
Other
Arm Description
Received exclusive enteral nutrition after enrollment.
Intervention Type
Dietary Supplement
Intervention Name(s)
Exclusive Enteral Nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
5-item gut microbiota measure
Description
the change of gut microbiota during EEN and after the end of EEN
Time Frame
0, 2, 6, 8, 12 weeks post-EEN
Title
2-item Simple Endoscopic Score for CD (SES-CD)
Description
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)
Time Frame
0, 8, weeks post-EEN
Secondary Outcome Measure Information:
Title
5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)
Description
wPCDAI scoret included 8 items (Abdominal pain, Patient functioning, Stools, ESR, Albumin, Weight, Perirectal disease, Extraintestinal manifestations ).
Time Frame
0, 2, 6, 8, 12 weeks post-EEN
Title
2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)
Description
the level of 25-OH VITD3 in 8 weeks post-EEN is higher than 0 week represents a better outcome
Time Frame
0,8 weeks post-EEN
Title
5-item weight measure
Time Frame
0, 2, 6, 8, 12 weeks post-EEN
Title
5-item height measure
Time Frame
0, 2, 6, 8, 12 weeks post-EEN
Title
5-item Fecal Calprotectin
Time Frame
0, 2, 6, 8, 12 weeks post-EEN
Title
2-item Insulin-like growth factor-1
Time Frame
0, 8 weeks post-EEN
Title
2-item Calcium, vitamin
Time Frame
0, 8 weeks post-EEN

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's hospital of Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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