NCT07210658RecruitingNot Applicable
Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.
Société des Produits Nestlé (SPN)1 site in 1 country25 target enrollmentStarted: April 14, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Gastrointestinal tolerance
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 16 Years (Child)
- Sex
- 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
- •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
Arms & Interventions
Children will act as their own control for the nutritional product
Other
Intervention: Oral nutritional supplementation (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Formula intake in mLs(28 days)
Investigators
Study Sites (1)
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