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

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03048409
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Actual Duration (Months): 14.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enteral Feeding Intolerance	Other: Enteral Formula

Study Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula
• Actual Study Start Date: Jul 24, 2017
• Actual Primary Completion Date: Oct 2, 2018
• Actual Study Completion Date: Oct 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Enteral tube fed adults Enteral formula	Other: Enteral Formula; Enteral feeding with a peptide-based formula.

Outcome Measures

Primary Outcome Measures

1. Feeding tolerance - Gastric residuals [Up to 30 days after formula switch]

   no change, tolerance improved, tolerance worsened

2. Feeding tolerance - gagging/retching [Up to 30 days after formula switch]

   no change, tolerance improved, tolerance worsened

3. Feeding tolerance - abdominal distension/gas [Up to 30 days after formula switch]

   no change, tolerance improved, tolerance worsened

4. Feeding tolerance - vomiting [Up to 30 days after formula switch]

   no change, tolerance improved, tolerance worsened

5. Feeding tolerance - stool consistency issues [Up to 30 days after formula switch]

   too hard, too loose

6. Volume of formula consumed in a day vs. goal [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 [Up to 30 days after formula switch]

   Number of tube feeding interruptions

Secondary Outcome Measures

1. Weight [Prior to and up to 30 days following formula switch.]

   Measured body weight

2. Medication use [Prior to and up to 30 days following formula switch.]

   Documented medication use

3. Caloric intake [Up to 30 days after formula switch]

   Measured daily calorie intake

4. Protein intake [Up to 30 days after formula switch]

   Measured daily protein intake

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bruyere Research Institute	Ottawa	Ontario	Canada

Sponsors and Collaborators

• Nestlé

Investigators

• Principal Investigator: Jean Chouinard, MD, St. Vincent's Hospital-Manhattan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT03048409
• Other Study ID Numbers: 16.06.US.HCN
• First Posted: Feb 9, 2017
• Last Update Posted: Jul 12, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 12, 2019