Enteral Formula Tolerance of Standard Tube Feedings

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02312271
• Collaborator: (none)
• Enrollment: 102
• Locations: 3
• Duration (Months): 28
• Patients Per Site: 34
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Condition or Disease	Intervention/Treatment	Phase
Enteral Feeding	Other: enteral formula

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
enterally fed adults adult subjects with established enteral access receiving standard tube feeding formula	Other: enteral formula; standard tube feeding formulas

Outcome Measures

Primary Outcome Measures

1. Daily percentage of caloric nutritional goal met [21 days]

Secondary Outcome Measures

1. Daily percentage of protein goal met [21 days]

2. GI tolerance [21 days]

3. Adverse events and serious adverse events [21 days]

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

• Currently tolerating enteral feeding

• Has enteral access

• Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days

• Having obtained his/her and/or his/her legal representative's informed consent.

Exclusion Criteria:

• Condition which contraindicates enteral feeding (i.e. intestinal obstruction)

• Lack of enteral access

• Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)

• Currently participating in another conflicting clinical study that would interfere with anticipated endpoints

• Judged to be at risk for poor compliance to the study protocol.

• Lack of informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas	Little Rock	Arkansas	United States
2	Vanderbilt University	Nashville	Tennessee	United States
3	Bruyere Research Institute	Ottawa	Ontario	Canada

Sponsors and Collaborators

• Nestlé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT02312271
• Other Study ID Numbers: 14.01.US.HCN
• First Posted: Dec 9, 2014
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

Study Results

No Results Posted as of May 31, 2017