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NCT Number: NCT04999241

Combined Application of EEN in the Induction of Remission in PUC

The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week12 will be compared between the two groups (combine with EEN group VS non-combine group).

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Key information

Conditions

Exclusive Enteral Nutrition Children Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed UC
  • Years 6 to 18
  • Moderate to severe disease activity at diagnosis

Exclusion criteria

  • With mild disease activity at diagnosis
  • Had been treated with corticosteroids or biologics

Treatment and study plan

exclusive enteral nutrition

Combination Product

Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.

Other names: corticosteroids, infliximab, 5-ASA, AZA

regular food

Combination Product

Administration of regular food in the induction phase and the later time.

Other names: corticosteroids, infliximab, 5-ASA, AZA

Primary outcomes

  1. The mucosal healing rate

    Time frame: 12 week after intervention

    The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.

Secondary outcomes

  1. sustained corticosteroid-free clinical remission rate

    Time frame: 1 year after intervention

    Sustained pediatric Ulcerative Colitis activity index (PUCAI) score <10 points during follow-up (week 14 to week 54 after intervention) without the treatment of corticosteroids . This will be evaluated by gastroenterologist.

  2. Treatment modification rate

    Time frame: 1 year after intervention

    The rate of new treatment measures needed to be started due to worsening of symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Cui fang Zheng

CONTACT

[email protected]

8615221881022

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

The Role of Combined Application of Exclusive Enteral Nutrition in the Induction of Remission for Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2021
Registry last updated
Jul 3, 2024

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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