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

ConditionsCrohn DiseaseNutrition DisordersSurgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWei Zhou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

elective bowel resection for Crohn's disease;

preoperative diagnosis of Crohn's disease;

age between 18 to 65 years old;

malnutrition;

Disqualifiers

emergency surgery;

preoperative exclusive enteral nutrition before three months;

can not tolerate enteral nutrition;

less than 6 weeks of exclusive enteral nutrition;

Trial design

Design model

Parallel

Treatments tested in this trial

  • peptison liquid

    Dietary supplement

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

  • Enteral nutritional suspension

    Dietary supplement

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

Treatment groups

304 Participants
are divided into 2 treatment groups
Group A: SED patientExperimental treatment 1 intervention
Group B: PD patientPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change of CRP/ALB level

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

Time frame
6 weeks

Secondary outcomes

1

BMI

The BMI level changed after exclusive enteral nutrition.

Time frame
6 weeks
2

CDAI

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

Time frame
6 weeks
3

postoperative complications

The incidence of postoperative complications in two groups.

Time frame
6 weeks
4

adverse reaction

The incidence of adverse reaction during exclusive enteral nutrition.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wei Zhou

Lead sponsor

Sir Run Run Shaw Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: