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RecruitingNCT07210658Updated Jan 9, 2026

Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.

An interventional study of Oral nutritional supplementation in Paediatrics, sponsored by Société des Produits Nestlé (SPN). Recruiting at 1 site in United Kingdom. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2025, registered Jul 2025).
  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
1 Year to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Paediatrics

Keywords

  • Acceptability
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    Children will act as their own control for the nutritional product

    Dietary Supplement: Oral nutritional supplementation

Interventions

  • Dietary supplementOral nutritional supplementation

    As directed by the HCP

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
  • Dietetics
    Nottingham, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07210658
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Oct 7, 2025
Start date
Apr 14, 2025
Primary completion
Nov 10, 2025
Completion
May 15, 2026 (estimated)
Last update
Jan 9, 2026

Study contacts

Sharan Saduera, BSc (Hons) Dietetics
Contact
sharan.saduera@uk.nestle.com
+447557170649

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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