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NCT Number: NCT03755583

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Enteral Nutrition Gastroenteritis Gastrointestinal Diseases Gastrointestinal Microbiome Inflammatory Bowel Diseases Intestinal Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exclusive Enteral Nutrition

Dietary Supplement

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.

Primary outcomes

  1. 5-item gut microbiota measure

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

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

  2. 2-item Simple Endoscopic Score for CD (SES-CD)

    Time frame: 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 outcomes

  1. 5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)

    Time frame: 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. 2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)

    Time frame: 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

  3. 5-item weight measure

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

  4. 5-item height measure

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

  5. 5-item Fecal Calprotectin

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

  6. 2-item Insulin-like growth factor-1

    Time frame: 0, 8 weeks post-EEN

  7. 2-item Calcium, vitamin

    Time frame: 0, 8 weeks post-EEN

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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