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

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Fudan University

Status

Completed

Conditions

Enteral Nutrition
Gastrointestinal Microbiome
Crohn Disease

Treatments

Dietary Supplement: Exclusive Enteral Nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT03755583
IBD-EEN-microbiota

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

1 to 17 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

EEN group
Other group
Description:
Received exclusive enteral nutrition after enrollment.
Treatment:
Dietary Supplement: Exclusive Enteral Nutrition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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