Food for Special Medical Purpose in Patients With Digestive Tract Tumor

Status Completed

Clinical Trial Summary

This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period.

Clinical Trial Description

This is a prospective, randomized, controlled, unblinded, parallel, and multicenter, and non-inferiority study to demonstrate the safety and efficacy of a FSMP in participants with digestive tract tumor undergoing surgical resection during the perioperative period. Half of the participants will receive FSMP, the other half will receive Enteral Nutrition Emulsion (TPF-T) as an active control. Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study, to demonstrate its parity with TPF-T on efficacy and safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05301556
Study type	Interventional
Source	Abbott Nutrition
Contact
Status	Completed
Phase	N/A
Start date	June 24, 2022
Completion date	January 9, 2024

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