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OpenTrials
Completed

NCT Number: NCT02312271

Enteral Formula Tolerance of Standard Tube Feedings

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Completed

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Key information

Conditions

Enteral Feeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bruyere Research Institute, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years of age
  • Currently tolerating enteral feeding
  • Has enteral access
  • Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days
  • Having obtained his/her and/or his/her legal representative's informed consent.

Exclusion criteria

  • Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
  • Lack of enteral access
  • Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
  • Currently participating in another conflicting clinical study that would interfere with anticipated endpoints
  • Judged to be at risk for poor compliance to the study protocol.
  • Lack of informed consent.

Treatment and study plan

Enteral Formula

Other

standard tube feeding formulas

Primary outcomes

  1. Daily percentage of caloric nutritional goal met

    Time frame: 21 days

Secondary outcomes

  1. Daily percentage of protein goal met

    Time frame: 21 days

  2. GI tolerance

    Time frame: 21 days

  3. Adverse events and serious adverse events

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2014
Registry last updated
May 31, 2017

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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