PaediatricsNCT07210658
Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
A study testing Oral nutritional supplementation in people with Paediatrics, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
Acceptability, compliance and palatability study. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Paediatrics
- What is being tested?
- Oral nutritional supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement as part of their dietary management for disease related malnutrition.
- Patients well-established and stable on current nutritional support regimen.
- Willingly given, written, informed consent from patient/caregiver.
Who cannot join
- Unsafe swallow
- Inability to comply with the study protocol, in the opinion of the investigator.
- Under 1 years of age
- Patients on total parenteral nutrition
- Known food allergies, including any allergies to the ingredients
- Patients with Chronic Kidney Disease (CKD) stage 3b (G3b), stage 4 (G4), stage 5 (G5) or hepatic impairment.
- Participation in another interventional study within 2 weeks of this study.
- Patients with known or suspected ileus or mechanical bowel obstruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Dietetics
Nottingham
Nutrition and Dietetics, s.durnan@nhs.net
About this study
Official title: Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.
Acceptability, compliance and palatability study.
Read the detailed description
Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.
- Conditions
- Paediatrics
- Being tested
- Oral nutritional supplementation
- Keywords
- Acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementationDietary supplement
As directed by the HCP
| Study group | Role | What they receive |
|---|---|---|
| Children will act as their own control for the nutritional product | Other | Not described Receives: Dietary Supplement: Oral nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Number of children who experienced gastrointestinal symptoms such as reflux, vomiting, nausea, constipation, diarrhoea recorded as a 4 point Likert scale as none, mild, moderate, severe symptoms at baseline and at post switch.
Measured: Days 1-7, and at day 14, 21 and 28
Secondary outcomes (1)
Formula intake in mLs
The amount of mLs of formula intake by patient compared to what was prescribed in mLs.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start14 Apr 2025
- Primary completion10 Nov 2025
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PaediatricsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children will act as their own control.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
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
- NCT07210658
- Sponsor's protocol ID
- ONS FB 001
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.
- ClinicalTrials.gov ID
- NCT07210658
- Acronym / sponsor ID
- ONS FB 001
- Conditions
- Paediatrics
- Keywords
- Acceptability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 7 Oct 2025 (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.
Acceptability, compliance and palatability study.
Detailed description
Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children will act as their own control.
| Arm | Type | Receives |
|---|---|---|
| Children will act as their own control for the nutritional product | Other | Dietary Supplement: Oral nutritional supplementation |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement as part of their dietary management for disease related malnutrition.
- Patients well-established and stable on current nutritional support regimen.
- Willingly given, written, informed consent from patient/caregiver.
Key exclusion criteria (8 listed)
- Unsafe swallow
- Inability to comply with the study protocol, in the opinion of the investigator.
- Under 1 years of age
- Patients on total parenteral nutrition
- Known food allergies, including any allergies to the ingredients
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 |
|---|---|---|
| Oral nutritional supplementationAs directed by the HCP | Dietary supplement | Children will act as their own control for the nutritional product |
Primary outcome
Gastrointestinal tolerance
Time frame: Days 1-7, and at day 14, 21 and 28
Number of children who experienced gastrointestinal symptoms such as reflux, vomiting, nausea, constipation, diarrhoea recorded as a 4 point Likert scale as none, mild, moderate, severe symptoms at baseline and at post switch.
1 secondary outcome
Formula intake in mLs
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplementation in people with Paediatrics, 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharan Saduera, BSc (Hons) Dietetics (+447557170649, sharan.saduera@uk.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance (time frame: Days 1-7, and at day 14, 21 and 28). 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 9 Jan 2026.