Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03048409
Acronym
RAP
Enrollment
10
Registered
2017-02-09
Start date
2017-07-24
Completion date
2018-10-02
Last updated
2019-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding Intolerance

Brief 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.

Interventions

Enteral feeding with a peptide-based formula.

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Tube feeding interruptionsUp to 30 days after formula switchNumber of tube feeding interruptions
Feeding tolerance - abdominal distension/gasUp to 30 days after formula switchno change, tolerance improved, tolerance worsened
Feeding tolerance - vomitingUp to 30 days after formula switchno change, tolerance improved, tolerance worsened
Feeding tolerance - stool consistency issuesUp to 30 days after formula switchtoo hard, too loose
Volume of formula consumed in a day vs. goalUp to 30 days after formula switchdocumentation of feeding volume after switch as less than, about the same as, or more than feeding volume achieved before switch
Feeding tolerance - Gastric residualsUp to 30 days after formula switchno change, tolerance improved, tolerance worsened
Feeding tolerance - gagging/retchingUp to 30 days after formula switchno change, tolerance improved, tolerance worsened

Secondary

MeasureTime frameDescription
Medication usePrior to and up to 30 days following formula switch.Documented medication use
Caloric intakeUp to 30 days after formula switchMeasured daily calorie intake
Protein intakeUp to 30 days after formula switchMeasured daily protein intake
WeightPrior to and up to 30 days following formula switch.Measured body weight

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026