Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

Nestlé

Status and phase: Completed; Phase 4

Conditions: Severe Burn Patients; Infections on

Treatments: Dietary Supplement: Sondalis HP; Dietary Supplement: Crucial

Study type: Interventional

Funder types: Industry

Identifiers

NCT00561210

NCNF 0501

Details and patient eligibility

About

Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

Enrollment: 57 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thermic burn from 20% to 80%
• 15 < age < 70 years
• written informed consent

Exclusion criteria

• diabetes mellitus
• corticoid or immuno-suppressive therapy
• HIV
• evolutive cancers
• pregnancy
• abdominal lesion
• hepatic or renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

I

Experimental group

Description:

Total enteral tube feeding

Treatment:

Dietary Supplement: Crucial

II

Active Comparator group

Description:

Total enteral tube feeding

Treatment:

Dietary Supplement: Sondalis HP