Enteral FeedingNCT05838495
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
A study testing formulated liquid diet in people with Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- formulated liquid diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to 6 Jul 2024
- 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medically stable, enterally tube-fed children
- Aged 1 to 13 years (inclusive) at the time of screening.
- Currently tolerating enteral feeding and should be appropriate for study formula
- Requires enteral tube feeding to provide 90% or more of their nutritional needs
- signed informed consent
Who cannot join
- Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
- Currently using or has previously used the study product
- Any medical condition or contraindicated medications that would contraindicate use of the study product
- Any illness within ~5-7 days of screening and/or baseline lasting >48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
- Participation in another interventional clinical study
- Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
Read the detailed description
The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.
- Conditions
- Enteral Feeding
- Being tested
- formulated liquid diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formulated liquid dietOther
will be fed exclusively the pediatric enteral study formula with a feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Enteral tube fed children | Experimental | Children being fed an enteral formula with a feeding tube Receives: Other: formulated liquid diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional efficacy - energy
Percent of daily calorie nutritional goals met
Measured: 14 days
Secondary outcomes (5)
Nutritional efficacy - protein
Percent of daily protein nutritional goals met
Measured: 14 days
Frequency of nausea
Daily frequency of nausea for each participant
Measured: 14 days
Frequency of vomiting
Daily frequency of vomiting for each participant
Measured: 14 days
Bristol Stool Chart
Daily reporting of stool parameters using Bristol stool chart. Scale from 1-7. Type 1: Separate hard lumps (hard to pass) Type 2: Lumpy, hard, sausage-shaped Type 3: Sausage-shaped with cracks on the surface Type 4: Sausage-shaped or snake-like; smooth and soft Type 5: Soft blobs with clear-cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges; mushy Type 7: Entirely liquid, watery, no solid pieces
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 posted1 May 2023
- Study start1 Jun 2023
- Primary completion5 Jul 2024
- Study completion6 Jul 2024
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
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessie Hulst, MD, Principal investigator, The Hospital for Sick ChildrenCindy Steel, MSc, Study chair, Nestle Health Science CanadaKrys Araujo Torres, MD, Study director, Nestle Health Science USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838495
- Sponsor's protocol ID
- N02-20-01-T0004
- Other IDs
- 22.01.CA.HCN
- Status last verified
- Nov 2024
- First submitted
- 5 Apr 2023
- 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
- A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients
- ClinicalTrials.gov ID
- NCT05838495
- Acronym / sponsor ID
- N02-20-01-T0004
- Conditions
- Enteral Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 1 May 2023 (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.
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
Detailed description
The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.
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 children | Experimental | Other: formulated liquid dietChildren being fed an enteral formula with a feeding tube |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Medically stable, enterally tube-fed children
- Aged 1 to 13 years (inclusive) at the time of screening.
- Currently tolerating enteral feeding and should be appropriate for study formula
- Requires enteral tube feeding to provide 90% or more of their nutritional needs
- signed informed consent
Key exclusion criteria (6 listed)
- Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
- Currently using or has previously used the study product
- Any medical condition or contraindicated medications that would contraindicate use of the study product
- Any illness within ~5-7 days of screening and/or baseline lasting >48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
- Participation in another interventional clinical study
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 |
|---|---|---|
| formulated liquid dietwill be fed exclusively the pediatric enteral study formula with a feeding tube | Other | Enteral tube fed children |
Primary outcome
Nutritional efficacy - energy
Time frame: 14 days
Percent of daily calorie nutritional goals met
5 secondary outcomes
Nutritional efficacy - protein
Time frame: 14 days
Frequency of nausea
Time frame: 14 days
Frequency of vomiting
Time frame: 14 days
Bristol Stool Chart
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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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.
Jessie Hulst, MD principal investigator
The Hospital for Sick Children
Cindy Steel, MSc study chair
Nestle Health Science Canada
Krys Araujo Torres, MD study director
Nestle Health Science USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing formulated liquid diet in people with Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
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 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 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?
Nutritional efficacy - energy (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.