At a glance
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A Single Arm Intervention Study to Assess the Acceptability, Tolerance and Ease of Use of Wilbo's Blends+ (Commercial Enteral Feed Based on Real Food) When Used as Part of a Dietitian Prescribed Enteral Feeding Plan
In Brief
A clinical study evaluating Wilbo's Blends+ for Enteral Nutrition (Food for Special Medical Purposes) and 3 related conditions. Completed, enrolled 45 participants across 1 site.
Detailed Summary
The goal of this observational study is to learn if tube-fed children and young people (age 3-15 years) find Wilbo's Blends+ (a new nutritionally complete enteral formula containing real food ingredients) acceptable, tolerable and easy to use. The main question it aims to answer is: Is Wilbo's Blends+ acceptable when included in the feeding plan of tube-fed children and young people (age 3-15 years) Participants will: Take Wilbo's Blend+ for a 7 day period as part of their feeding plan Complete questionnaires about their gastrointestinal symptoms
Study Details
Timeline
Interventions
A new feeding plan will be developed by the study dietitians. Participants will be transitioned from their current enteral feeding plan to incorporate Wilbo's Blends+. In this new plan Wilbo's Blends+ can provide up to 100% but not lower than 30% of their total daily calorie requirements depending on participant's individual clinical needs, as assessed by the study dietitian. All participants will be on at least 30% Wilbo's Blends+ for at least 7 days. If required clinically there is the option to transition participants onto Wilbo's Blends+ over 1-6 days, for children who are deemed particularly sensitive to change in their feeding plan. Participants or their families/carers will complete an electronic workbook consisting of: * GI tolerance records for 7 days whilst receiving Wilbo's Blends+ * Compliance records for 7 days whilst receiving Wilbo's Blends+ * Ease of use and palatability questionnaire at the end of the study intervention (after last administration of Wilbo's Blends+