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OpenTrials
Completed

NCT Number: NCT03048409

Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula

A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bruyere Research Institute

Ottawa, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years of age on admission to facility
  • Prescribed enteral nutrition with the goal to provide at least 90% of estimated daily calorie and protein requirements for ≥ 2 weeks prior to switch
  • Received enteral nutrition with an intact protein formula for a minimum of three days prior to a switch to a peptide-based formula
  • Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a peptide-based formula
  • Receiving a peptide-based formula formula for ≥ 2 weeks
  • Have documentation of an assessment of feeding tolerance following the switch
  • Formulas received must be indicated for use in adults.

Exclusion criteria

  • Abdominal surgery (within past 30 days prior to switch)
  • Having any infection, including upper respiratory, viral, gastroenteritis,wound infections, c difficile, at time of switch
  • Having documented cow's milk protein allergy at time of switch
  • Medical records lacking information on rationale for switch to a peptide-based formula and/or response to change (positive, neutral or negative).

Treatment and study plan

Enteral Formula

Other

Enteral feeding with a peptide-based formula.

Primary outcomes

  1. Feeding tolerance - Gastric residuals

    Time frame: Up to 30 days after formula switch

    no change, tolerance improved, tolerance worsened

  2. Feeding tolerance - gagging/retching

    Time frame: Up to 30 days after formula switch

    no change, tolerance improved, tolerance worsened

  3. Feeding tolerance - abdominal distension/gas

    Time frame: Up to 30 days after formula switch

    no change, tolerance improved, tolerance worsened

  4. Feeding tolerance - vomiting

    Time frame: Up to 30 days after formula switch

    no change, tolerance improved, tolerance worsened

  5. Feeding tolerance - stool consistency issues

    Time frame: Up to 30 days after formula switch

    too hard, too loose

  6. Volume of formula consumed in a day vs. goal

    Time frame: Up to 30 days after formula switch

    documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch

  7. Tube feeding interruptions

    Time frame: Up to 30 days after formula switch

    Number of tube feeding interruptions

Secondary outcomes

  1. Weight

    Time frame: Prior to and up to 30 days following formula switch.

    Measured body weight

  2. Medication use

    Time frame: Prior to and up to 30 days following formula switch.

    Documented medication use

  3. Caloric intake

    Time frame: Up to 30 days after formula switch

    Measured daily calorie intake

  4. Protein intake

    Time frame: Up to 30 days after formula switch

    Measured daily protein intake

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Acronym: RAP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2017
Registry last updated
Jul 12, 2019

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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