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

Children's Hospital of Fudan University31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease Enteral Nutrition Gastrointestinal Microbiome

Interventions

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

5-item gut microbiota measure

the change of gut microbiota during EEN and after the end of EEN

Time frame: 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)

Time frame: 0, 8, weeks post-EEN

Secondary Outcomes

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 ).

Time frame: 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

Time frame: 0,8 weeks post-EEN

5-item weight measure

Time frame: 0, 2, 6, 8, 12 weeks post-EEN

5-item height measure

Time frame: 0, 2, 6, 8, 12 weeks post-EEN

5-item Fecal Calprotectin

Time frame: 0, 2, 6, 8, 12 weeks post-EEN

2-item Insulin-like growth factor-1

Time frame: 0, 8 weeks post-EEN

2-item Calcium, vitamin

Time frame: 0, 8 weeks post-EEN

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes