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

Wei Zhou

Status: Not yet enrolling

Conditions: Nutrition Disorders; Surgery; Crohn Disease

Treatments: Dietary Supplement: peptison liquid; Dietary Supplement: Enteral nutritional suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT06587178

20210323-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 304 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 2 patient groups, including a placebo group

SED patient

Experimental group

Description:

SED patients who received semi-elemental exclusive enteral nutrition.

Treatment:

Dietary Supplement: peptison liquid

PD patient

Placebo Comparator group

Description:

PD patients who received polymeric exclusive enteral nutrition.

Treatment:

Dietary Supplement: Enteral nutritional suspension