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Food for Special Medical Purpose in Patients With Digestive Tract Tumor

NCT05301556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-03-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Experimental Product

* Before the surgery: FSMP provides daily target energy needed by participants * 1-2 days after surgery: Start FSMP and advance as tolerated to achieve 20% of the daily target energy needed by participants * 3rd-5th day after surgery: Gradually increase FSMP intake every day as tolerated to provide 30-80% of the daily target energy needed by participants * 6th to 11th day after surgery. FSMP provides daily target energy needed by participants

OTHER

Control Product

* Before surgery: TPF-T provides daily target energy needed by participants * 1-2 days after surgery: Start TPF-T and advance as tolerated to achieve 20% of the daily target energy needed by participants * 3rd-5th day after surgery: Gradually increase TPF-T intake every day as tolerated to provide 30-80% of the daily target energy needed by participants * 6th to 11th day after surgery. TPF-T provides daily target energy needed by participants

Sponsors & Collaborators

  • Abbott Nutrition

    lead INDUSTRY

Principal Investigators

  • Shengqi Li, PhD · Abbott Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2024-01-09
Completion
2024-01-09

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301556 on ClinicalTrials.gov