Nutrition Disorder, ChildNCT04515940
Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children
An observational study of Nutrition Disorder, Child, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Nutrition Disorder, Child
- What is being tested?
- acceptability, tolerance and palatability study
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2019to 29 Sep 2020
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: paediatric children 1- 10 years
Who may be able to join
- Children aged 1 year and over who require 1-3 bottles of an oral nutritional peptide based supplement drink II. Children who require an oral nutritional supplement or who are already established on a nutritional supplement drink III. Children who require a nutritional supplement drink as bolus feeding via a feeding tube.
- Children being able to communicate views of acceptability V. Willingly given, written, informed consent from patient or parent/guardian. VI. Willingly given, written assent (if appropriate).
Who cannot join
- Inability to comply with the study protocol, in the opinion of the investigator.
- Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Require a milk free diet IV. Children under the age of 12 months V. Emergencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance and Palatability) of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children Over 12 Months of Age
This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.
The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
Read the detailed description
Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based oral nutritional supplement drink for the dietary management.
The ACBS requirement for evaluable data on 15 participants has informed the trial's recruitment target; however, we may need to exceed this target if any patients give their consent to join the study but then decide not to participate in the study. Participants who join the study and begin using the product would count towards the recruitment total and their data would be included in a submission to the ACBS whether they complete the 7-day study period or not.
Each potential participant must meet all of the inclusion criteria and not meet any of the exclusion criteria.
- Conditions
- Nutrition Disorder, Child
- Being tested
- acceptability, tolerance and palatability study
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acceptability, tolerance and palatability studyDietary supplement
prospective acceptability study
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Daily record via participant diary:
- Gastrointestinal tolerance:
- Diarrhoea and / or constipation
- Bloating and / or distension
- Nausea and / or vomiting
- Burping / flatulence / regurgitation
- Abdominal discomfort / pain/ back arching/ crying
- Participant compliance: How many feeds taken and volume prescribed each day
- Acceptability
Questionnaires to children and or parents for the evaluation of the acceptability and ease of use of the milk supplement drink Diarrhoea, constipation, bloating, distension, nausea, vomitting, burping, abdominal pain
Measured: Day 7 from baseline
Compliance
volume suggested versus consumed
Measured: Day 7 from baseline
Secondary outcomes (2)
weight in kg
At baseline
Measured: Day 8 from baseline
height in meters
At basline
Measured: Day 8 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start30 Oct 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorder, ChildStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Smith, Principal investigator, Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515940
- Sponsor's protocol ID
- ONS peptide 1.5
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2020
- Last updated
- 22 Oct 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance and Palatability) of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children Over 12 Months of Age
- ClinicalTrials.gov ID
- NCT04515940
- Acronym / sponsor ID
- ONS peptide 1.5
- Conditions
- Nutrition Disorder, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 17 Aug 2020 (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 an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.
The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
Detailed description
Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based oral nutritional supplement drink for the dietary management.
The ACBS requirement for evaluable data on 15 participants has informed the trial's recruitment target; however, we may need to exceed this target if any patients give their consent to join the study but then decide not to participate in the study. Participants who join the study and begin using the product would count towards the recruitment total and their data would be included in a submission to the ACBS whether they complete the 7-day study period or not.
Each potential participant must meet all of the inclusion criteria and not meet any of the exclusion criteria.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- paediatric children 1- 10 years
Key inclusion criteria (2 listed)
- Children aged 1 year and over who require 1-3 bottles of an oral nutritional peptide based supplement drink II. Children who require an oral nutritional supplement or who are already established on a nutritional supplement drink III. Children who require a nutritional supplement drink as bolus feeding via a feeding tube.
- Children being able to communicate views of acceptability V. Willingly given, written, informed consent from patient or parent/guardian. VI. Willingly given, written assent (if appropriate).
Key exclusion criteria (2 listed)
- Inability to comply with the study protocol, in the opinion of the investigator.
- Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Require a milk free diet IV. Children under the age of 12 months V. Emergencies
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 |
|---|---|---|
| acceptability, tolerance and palatability studyprospective acceptability study | Dietary supplement | – |
Primary outcome
Gastrointestinal tolerance
Time frame: Day 7 from baseline
Daily record via participant diary: 1. Gastrointestinal tolerance: * Diarrhoea and / or constipation * Bloating and / or distension * Nausea and / or vomiting * Burping / flatulence / regurgitation * Abdominal discomfort / pain/ back arching/ crying 2. Participant compliance: How many feeds taken and volume prescribed each day 3. Acceptability Questionnaires to children and or parents for the evaluation of the acceptability and ease of use of the milk supplement drink Diarrhoea, constipation, bloating, distension, nausea, vomitting, burping, abdominal pain
Compliance
Time frame: Day 7 from baseline
volume suggested versus consumed
2 secondary outcomes
weight in kg
Time frame: Day 8 from baseline
height in meters
Time frame: Day 8 from baseline
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 22 Oct 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.
Chris Smith principal investigator
Nutrition and Dietetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorder, Child, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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 2 inclusion and 2 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 22 Oct 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 Kingdom. 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?
Gastrointestinal tolerance (time frame: Day 7 from baseline). The study lists 2 primary outcomes in all. 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 22 Oct 2024.