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

Enteral Feeding Intolerance Clinical Trial

— RAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048409
• Other study ID #: 16.06.US.HCN
• Status: Completed
• Start date: July 24, 2017
• Est. completion date: October 2, 2018

Study information

• Verified date: July 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Enteral Feeding Intolerance

Intervention

Other:
• Enteral Formula
Enteral feeding with a peptide-based formula.

Locations

Country	Name	City	State
Canada	Bruyere Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding tolerance - Gastric residuals	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Primary	Feeding tolerance - gagging/retching	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Primary	Feeding tolerance - abdominal distension/gas	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Primary	Feeding tolerance - vomiting	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Primary	Feeding tolerance - stool consistency issues	too hard, too loose	Up to 30 days after formula switch
Primary	Volume of formula consumed in a day vs. goal	documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch	Up to 30 days after formula switch
Primary	Tube feeding interruptions	Number of tube feeding interruptions	Up to 30 days after formula switch
Secondary	Weight	Measured body weight	Prior to and up to 30 days following formula switch.
Secondary	Medication use	Documented medication use	Prior to and up to 30 days following formula switch.
Secondary	Caloric intake	Measured daily calorie intake	Up to 30 days after formula switch
Secondary	Protein intake	Measured daily protein intake	Up to 30 days after formula switch