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NCT Number: NCT06587178

Semi-elemental Versus Polymeric EEN in the Preoperative Optimization for Patients with CD

Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective bowel resection for Crohn's disease;
  • preoperative diagnosis of Crohn's disease;
  • age between 18 to 65 years old;
  • malnutrition;
  • the Crohn's disease activity index over 150;
  • nasal feeding.

Exclusion criteria

  • emergency surgery;
  • preoperative exclusive enteral nutrition before three months;
  • can not tolerate enteral nutrition;
  • less than 6 weeks of exclusive enteral nutrition;
  • preoperative corticosteroids within 3 months;
  • history of gastrointestinal surgery;
  • isolated colon disease;
  • metabolic disease (diabetes, hyperthyroidism).

Treatment and study plan

peptison liquid

Dietary Supplement

CD patients requiring bowel resection and preoperative EEN were randomized to receive peptison liquid for 6 weeks.

Other names: Nutricia, Amsterdam, Netherlands

Enteral nutritional suspension

Dietary Supplement

CD patients requiring bowel resection and preoperative EEN were randomized to receive enteral nutritional suspension for 6 weeks.

Other names: Nutricia, Amsterdam, Netherlands

Primary outcomes

  1. The change of CRP/ALB level

    Time frame: 6 weeks

    The ratio of C-reactive protein to albumin level changed after exclusive enteral nutrition.

Secondary outcomes

  1. BMI

    Time frame: 6 weeks

    The BMI level changed after exclusive enteral nutrition.

  2. CDAI

    Time frame: 6 weeks

    Crohn's disease activity index, from 0 to 600, the higher index shows more serious of CD.

  3. postoperative complications

    Time frame: 6 weeks

    The incidence of postoperative complications in two groups.

  4. adverse reaction

    Time frame: 6 weeks

    The incidence of adverse reaction during exclusive enteral nutrition.

Study contacts

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

Sponsors and collaborators

Lead sponsor

Wei Zhou

Other

Registry information

Official study title

Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial

Acronym: SEPEN-CD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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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