Crohn Disease, Enteral Nutrition, Gastrointestinal Microbiome
Conditions
Keywords
Exclusive enteral nutrition
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.
Interventions
DIETARY_SUPPLEMENTExclusive Enteral Nutrition
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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 2-item Calcium, vitamin | 0, 8 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 | — |
| 5-item height measure | 0, 2, 6, 8, 12 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 ). |
Countries
China
Outcome results
None listed