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

Study Overview
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Brief Summary
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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.

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

Conditions
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Enteral Feeding Intolerance

Intervention / Treatment
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* Other: Enteral Formula


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enteral tube fed adults<br>Enteral formula | Other: Enteral Formula<br>* Enteral feeding with a peptide-based formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding tolerance - Gastric residuals | no change, tolerance improved, tolerance worsened | Up to 30 days after formula switch | 
| Feeding tolerance - gagging/retching | no change, tolerance improved, tolerance worsened | Up to 30 days after formula switch | 
| Feeding tolerance - abdominal distension/gas | no change, tolerance improved, tolerance worsened | Up to 30 days after formula switch | 
| Feeding tolerance - vomiting | no change, tolerance improved, tolerance worsened | Up to 30 days after formula switch | 
| Feeding tolerance - stool consistency issues | too hard, too loose | Up to 30 days after formula switch | 
| 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 | 
| Tube feeding interruptions | Number of tube feeding interruptions | Up to 30 days after formula switch | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured body weight | Prior to and up to 30 days following formula switch. | 
| Medication use | Documented medication use | Prior to and up to 30 days following formula switch. | 
| Caloric intake | Measured daily calorie intake | Up to 30 days after formula switch | 
| Protein intake | Measured daily protein intake | Up to 30 days after formula switch |