Enteral FeedingNCT02312271
Enteral Formula Tolerance of Standard Tube Feedings
An observational study of Enteral Feeding, run by Société des Produits Nestlé (SPN) at 3 sites in 2 countries.
Trial summary
This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- enteral formula
- How many people
- 102 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2014to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with established enteral access receiving standard tube feeding formula
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Arkansas
Little Rock, Arkansas
Vanderbilt University
Nashville, Tennessee
About this study
This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.
- Conditions
- Enteral Feeding
- Being tested
- enteral formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral formulaOther
standard tube feeding formulas
| Study group | Role | What they receive |
|---|---|---|
| enterally fed adults | adult subjects with established enteral access receiving standard tube feeding formula Receives: Other: enteral formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily percentage of caloric nutritional goal met
Measured: 21 days
Secondary outcomes (3)
Daily percentage of protein goal met
Measured: 21 days
GI tolerance
Measured: 21 days
Adverse events and serious adverse events
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312271
- Sponsor's protocol ID
- 14.01.US.HCN
- Status last verified
- May 2017
- First submitted
- 5 Dec 2014
- Last updated
- 31 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Formula Tolerance of Standard Tube Feedings
- ClinicalTrials.gov ID
- NCT02312271
- Acronym / sponsor ID
- 14.01.US.HCN
- Conditions
- Enteral Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enterally fed adults | – | Other: enteral formulaadult subjects with established enteral access receiving standard tube feeding formula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with established enteral access receiving standard tube feeding formula
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral formulastandard tube feeding formulas | Other | enterally fed adults |
Primary outcome
Daily percentage of caloric nutritional goal met
Time frame: 21 days
3 secondary outcomes
Daily percentage of protein goal met
Time frame: 21 days
GI tolerance
Time frame: 21 days
Adverse events and serious adverse events
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Feeding, run by Société des Produits Nestlé (SPN) at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily percentage of caloric nutritional goal met (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.