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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease, Enteral Nutrition, Gastrointestinal Microbiome

Intervention / Treatment
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* Dietary Supplement: Exclusive Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EEN group<br>Received exclusive enteral nutrition after enrollment. | Dietary Supplement: Exclusive Enteral Nutrition<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exclusive enteral nutrition