Actively Recruiting
Acceptability Including Gastrointestinal Tolerance, Compliance and Palatability of a Pediatric Oral Nutritional Supplement Containing Food Blends
Led by Société des Produits Nestlé (SPN) · Updated on 2026-01-09
25
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the acceptability of a pediatric oral nutritional supplement containing food blends. It focuses on assessing gastrointestinal tolerance, how well children comply with the supplement, and the palatability of the product. The study includes children aged 1 to 16 years who require nutritional support due to disease-related malnutrition and are stable on their current nutritional regimen. Participants will receive the oral nutritional supplement as directed by their healthcare provider. Children will act as their own control during the study period, which involves monitoring their response to the nutritional product. The study does not include masking or placebo groups and is observational regarding the supplement's acceptability. During the study, researchers will monitor gastrointestinal tolerance daily for the first week and then on days 14, 21, and 28. They will also measure the volume of formula intake over 28 days. The study involves regular assessments to track compliance, tolerance, and palatability, providing a comprehensive understanding of how the supplement is accepted by pediatric patients over the study duration.
CONDITIONS
Brief Title
Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 to 15 years requiring one or more oral nutritional supplements to replace current supplements for disease-related malnutrition
- Patients well-established and stable on their current nutritional support regimen
- Written informed consent provided by patient or caregiver
You will not qualify if you...
- Unsafe swallow
- Inability to comply with the study protocol, as judged by the investigator
- Under 1 year of age
- Patients receiving total parenteral nutrition
- Known food allergies, including allergies to any ingredients in the supplement
- Patients with Chronic Kidney Disease stage 3b, 4, 5 or hepatic impairment
- Participation in another interventional study within 2 weeks prior
- Patients with known or suspected ileus or mechanical bowel obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants take the pediatric oral nutritional supplement containing food blends as directed by their healthcare provider.
Multiple visits during the 28-day period to monitor gastrointestinal tolerance and compliance
Trial Site Locations
Total: 1 location
1
Dietetics
Nottingham, United Kingdom
Actively Recruiting
Research Team
S
Sharan Saduera, BSc (Hons) Dietetics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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