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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Crohn Disease Nutrition Disorders Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SED patient

SED patients who received semi-elemental exclusive enteral nutrition.

Group Type EXPERIMENTAL

peptison liquid

Intervention Type DIETARY_SUPPLEMENT

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

PD patient

PD patients who received polymeric exclusive enteral nutrition.

Group Type PLACEBO_COMPARATOR

Enteral nutritional suspension

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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peptison liquid

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

Intervention Type DIETARY_SUPPLEMENT

Enteral nutritional suspension

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutricia, Amsterdam, Netherlands Nutricia, Amsterdam, Netherlands

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No