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

Not Applicable

Completed

• Conditions: Crohn Disease; Gastrointestinal Microbiome; Enteral Nutrition
• Interventions: Dietary Supplement: Exclusive Enteral Nutrition

• Registration Number: NCT03755583
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-11-18
• Study First Submitted QC: 2018-11-24
• Study First Posted: 2018-11-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEN group	Exclusive Enteral Nutrition	Received exclusive enteral nutrition after enrollment.

Primary Outcome Measures

Name	Time	Method
5-item gut microbiota measure	0, 2, 6, 8, 12 weeks post-EEN	the change of gut microbiota during EEN and after the end of EEN
2-item Simple Endoscopic Score for CD (SES-CD)	0, 8, weeks post-EEN	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

Name	Time	Method
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
5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)	0, 2, 6, 8, 12 weeks post-EEN	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)	0,8 weeks post-EEN	the level of 25-OH VITD3 in 8 weeks post-EEN is higher than 0 week represents a better outcome
5-item weight measure	0, 2, 6, 8, 12 weeks post-EEN

Trial Locations

Locations (1)

Children's hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China