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Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.

N

Nestlé

Status

Enrolling

Conditions

Paediatrics

Treatments

Dietary Supplement: Oral nutritional supplementation

Study type

Interventional

Funder types

Industry

Identifiers

NCT07210658
ONS FB 001

Details and patient eligibility

About

Acceptability, compliance and palatability study.

Full description

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

Enrollment

25 estimated patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Children will act as their own control for the nutritional product
Other group
Treatment:
Dietary Supplement: Oral nutritional supplementation

Trial contacts and locations

1

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Central trial contact

Sharan Saduera, BSc (Hons) Dietetics

Data sourced from clinicaltrials.gov

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