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

NCT06587178 | Not Yet Recruiting

• 1 other identifier: 20210323-11
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease; Nutrition Disorders; Surgery

Keywords

Crohn's disease; Exclusive enteral nutrition; surgery

Outcome Measures

Primary Outcomes (1)

• The change of CRP/ALB level

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

  6 weeks

Secondary Outcomes (4)

• BMI

  6 weeks

• CDAI

  6 weeks

• postoperative complications

  6 weeks

• adverse reaction

  6 weeks

Study Arms (2)

SED patient

EXPERIMENTAL

SED patients who received semi-elemental exclusive enteral nutrition.

Dietary Supplement: peptison liquid

PD patient

PLACEBO COMPARATOR

PD patients who received polymeric exclusive enteral nutrition.

Dietary Supplement: Enteral nutritional suspension

Interventions

peptison liquid DIETARY_SUPPLEMENT

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

Also known as: Nutricia, Amsterdam, Netherlands

SED patient

Enteral nutritional suspension DIETARY_SUPPLEMENT

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

Also known as: Nutricia, Amsterdam, Netherlands

PD patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wei Zhou: lead

Study Sites (1)

Wei Zhou

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Crohn Disease; Nutrition Disorders

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Nutritional and Metabolic Diseases

Study Officials

• Xiujun Cai

  Sir Run Run Shaw Hospital

  STUDY CHAIR

Central Study Contacts

Wei Zhou

CONTACT

+8613588706479; zhouweisrrs@zju.edu.cn

Xiaolong Ge

CONTACT

+8613867106984; gxlmed@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)