Enteral FeedingNCT05025267
Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula
A study testing Medical Food: Peptide-Based Enteral Formula in people with Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula. 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?
- Medical Food: Peptide-Based Enteral Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 31 May 2023
- Phase
- Interventional
- 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
Who may be able to join
- Adults with established enteral access
- Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
- Signed informed consent
Who cannot join
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Any condition that would contraindicate use of the study product
- Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
- Judged to be at risk for poor compliance to the study protocol
- Participating in a conflicting clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Ability to Meet Nutritional Needs with a Peptide-based, High Protein Enteral Formula
This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.
Read the detailed description
This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.
- Conditions
- Enteral Feeding
- Being tested
- Medical Food: Peptide-Based Enteral Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food: Peptide-Based Enteral FormulaOther
Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Enteral Tube-fed Adults | Other | Adults being fed an enteral formula with a feeding tube Receives: Other: Medical Food: Peptide-Based Enteral Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie nutritional goals
Daily percentage of calorie nutritional goals met
Measured: 14 days
Secondary outcomes (3)
Protein nutritional goals
Daily percentage of protein nutritional goals met
Measured: 14 days
Daily reports of gastrointestinal intolerance
Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting)
Measured: 14 days
Adverse events
Daily adverse event reporting
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start31 Jan 2022
- Primary completion15 Apr 2023
- Study completion31 May 2023
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, non-randomized, open-label observational study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krysmaru Araujo Torres, MD, Study director, Nestle Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025267
- Sponsor's protocol ID
- 19.01.CA.HCN
- Status last verified
- Nov 2024
- First submitted
- 23 Aug 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Ability to Meet Nutritional Needs with a Peptide-based, High Protein Enteral Formula
- ClinicalTrials.gov ID
- NCT05025267
- Acronym / sponsor ID
- 19.01.CA.HCN
- Conditions
- Enteral Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 Aug 2021 (actual)
- 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 is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.
Detailed description
This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, non-randomized, open-label observational study
| Arm | Type | Receives |
|---|---|---|
| Enteral Tube-fed Adults | Other | Other: Medical Food: Peptide-Based Enteral FormulaAdults being fed an enteral formula with a feeding tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with established enteral access
- Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
- Signed informed consent
Key exclusion criteria (5 listed)
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Any condition that would contraindicate use of the study product
- Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
- Judged to be at risk for poor compliance to the study protocol
- Participating in a conflicting clinical trial
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 |
|---|---|---|
| Medical Food: Peptide-Based Enteral FormulaWill be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube | Other | Enteral Tube-fed Adults |
Primary outcome
Calorie nutritional goals
Time frame: 14 days
Daily percentage of calorie nutritional goals met
3 secondary outcomes
Protein nutritional goals
Time frame: 14 days
Daily reports of gastrointestinal intolerance
Time frame: 14 days
Adverse events
Time frame: 14 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 6 Nov 2024.
- Individual participant dataSharing planned: No
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Recruiting
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No DIET Trial: Dogmatic Interruption of Enteral nuTrition
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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.
Krysmaru Araujo Torres, MD study director
Nestle Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Food: Peptide-Based Enteral Formula in people with Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in United States.
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 3 inclusion and 5 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Calorie nutritional goals (time frame: 14 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 6 Nov 2024.