How well children tolerate and accept a new oral nutritional supplement
Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.
This test tries a pediatric oral nutritional supplement in children aged 1–15 to see if they tolerate it, can take it as recommended, and like the taste.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Sponsor | Société des Produits Nestlé (SPN) Industry-sponsored |
| Locations | 1 site (Nottingham) |
| Trial ID | NCT07210658 on ClinicalTrials.gov |
What this trial studies
Children who currently use an oral nutritional supplement and are stable on their regimen will replace their usual product with the investigational pediatric oral nutritional supplement and be followed for gastrointestinal tolerance, compliance, and palatability. Investigators will record intake adherence, collect caregiver- and patient-reported GI symptoms, and use short palatability questionnaires to rate taste and acceptability. Patients with unsafe swallow, significant kidney or liver impairment, ongoing total parenteral nutrition, known food allergies, or suspected bowel obstruction will be excluded. The study is sponsored by Société des Produits Nestlé and conducted at a Dietetics clinic in Nottingham.
Who should consider this trial
Good fit: Ideal candidates are children aged 1–15 who already need one or more oral nutritional supplements to manage disease-related malnutrition and are stable on their current nutritional regimen.
Not a fit: Children with unsafe swallow, on total parenteral nutrition, with known food allergies, advanced CKD (stage G3b–G5), significant hepatic impairment, or suspected ileus/mechanical bowel obstruction are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the product could provide a better-tolerated and more palatable oral supplement option to help children meet nutritional needs.
How similar studies have performed: Other acceptability and palatability studies of pediatric oral nutritional supplements have been performed previously and typically show product-specific, variable results rather than universal success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nottingham
- Dietetics — Nottingham, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sharan Saduera, BSc (Hons) Dietetics
- Email: sharan.saduera@uk.nestle.com
- Phone: +447557170649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.