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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

NCT07036081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-01

No results posted yet for this study

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

Conditions

  • Enteral Nutrition (Food for Special Medical Purposes)
  • Enteral Feeds
  • Enteral Tube Nutrition
  • Gastrostomy Tube

Interventions

DIETARY_SUPPLEMENT

Wilbo's Blends+

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+

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Wilbo's Blends

    collaborator UNKNOWN

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07036081 on ClinicalTrials.gov