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OpenTrials
Completed

NCT Number: NCT00561210

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

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

Completed

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Key information

Conditions

Infections on Infections Severe Burn Patients

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Pellegrin-Unites des brules, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crucial

Dietary Supplement

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

Sondalis HP

Dietary Supplement

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

Primary outcomes

  1. Number of infections and number of multiple organ failure

    Time frame: 6 months

Secondary outcomes

  1. digestive tolerance and healing

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Nov 20, 2007
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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