Recruiting NCT07210658
Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral nutritional supplementation.
- Who it may be relevant to
- Registry conditions: Paediatrics. Basic parameters: 1 year — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.
Overview
Acceptability, compliance and palatability study.
Detailed description
Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.
Interventions
- Dietary supplement Oral nutritional supplementation
As directed by the HCP
Primary outcome measures
- Gastrointestinal tolerance [Time frame: Days 1-7, and at day 14, 21 and 28]
Secondary outcome measures (1)
- Formula intake in mLs [Time frame: 28 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- Dietetics — Nottingham
Identifiers
NCT: NCT07210658 · ONS FB 001