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Recruiting

NCT Number: NCT07210658

Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.

Acceptability, compliance and palatability study.

Recruiting

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Key information

Conditions

Paediatrics

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dietetics

Nottingham, United Kingdom

Location status: Recruiting

Location contact

Nutrition and Dietetics

CONTACT

[email protected]

About this study

Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

oral nutritional supplementation

Dietary Supplement

As directed by the HCP

Primary outcomes

  1. 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.

Secondary outcomes

  1. Formula intake in mLs

    Time frame: 28 days

    The amount of mLs of formula intake by patient compared to what was prescribed in mLs.

Study contacts

Contact information is provided by the study sponsor or research team.

Sharan Saduera, BSc (Hons) Dietetics

CONTACT

[email protected]

+447557170649

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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