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 | Completed

• 2 other identifiers: 24CS011IUK10068044
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Enteral Tube Feeding; Gastrostomy Tube; Enteral Nutrition; Enteral Formula; Enteral Feeds

Outcome Measures

Primary Outcomes (1)

• Acceptability with regard to gastrointestinal tolerance

  Parents/carers will be asked to record gastrointestinal patterns and any symptoms (Diarrhoea, constipation, bloating, nausea, vomiting, burping, flatulence, regurgitation, abdominal pain or discomfort) using a questionnaire.

  Days 1-7

Secondary Outcomes (3)

• Ease of use

  Day 8

• To test where possible palatability of the Wilbo's Blends+ product.

  Day 8

• Health Care Team perceptions of Wilbo's Blends+.

  September 25-March 26

Study Arms (1)

• Children and young people (age 3-15) who are assessed by a Doctor or Dietitian as requiring entera

EXPERIMENTAL

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.

Dietary Supplement: Wilbo's Blends+

Interventions

Wilbo's Blends+ DIETARY_SUPPLEMENT

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+

• Children and young people (age 3-15) who are assessed by a Doctor or Dietitian as requiring entera

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and young people (age 3-15) who are assessed by a Doctor or Dietitian as requiring enteral tube feeding via gastrostomy.
• Children and young people able to receive a minimum of 30% of their daily intake from the study product for at least 7 consecutive days.
• Participant is capable of communication/filling in the questionnaires or having a parent/carer who can answer the questions by close observation of the participant reactions. If there are any communication issues the research dietitian/nurse should support. Written, informed consent from the parent/carer/guardian and assent from the participant obtained.

You may not qualify if:

• \<3 years old
• \>15 years old
• Total Parenteral Nutrition
• Post pyloric enteral feeding
• Enteral tube feeding via Nasogastric tube
• Patients with severe renal, oncology, metabolic, IBD or hepatic conditions who are considered clinically unstable
• Known food allergies or intolerances to any ingredient in the product
• Requirement of a fibre free feed (e.g. IBD)
• Children who had an inability to comply with the study protocol, in the opinion of the investigator
• Children who have been involved in another interventional study within 2 weeks of this study.
• Children with recent changes (within 1 week) in medication used to manage gastrointestinal symptoms

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Manchester: collaborator
• Wilbo's Blends: collaborator
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 SUH, United Kingdom

Location

Related Publications (8)

• Bobo E. Reemergence of Blenderized Tube Feedings: Exploring the Evidence. Nutr Clin Pract. 2016 Dec;31(6):730-735. doi: 10.1177/0884533616669703. Epub 2016 Sep 25.

  PMID: 27646862 BACKGROUND

• Marchesi JR, Allen S, Scott E, Jenkins H, Sadlier C, Thomas S. An observational investigation of the faical microbiota and metabonome of gastrostomy fed children, on blended and formula diets. Gut Microbes. 2022 Jan-Dec;14(1):2138661. doi: 10.1080/19490976.2022.2138661.

  PMID: 36284401 BACKGROUND

• Shrager S, Adigun A, Motolongo S, Santos CS, Rowe-King P, Duro D. Comparison of Home-Blenderized Formula and Commercial Enteral Formulas for Gastrostomy Tube-Fed Children: A Retrospective, Prospective Cohort Study. Cureus. 2023 Apr 21;15(4):e37944. doi: 10.7759/cureus.37944. eCollection 2023 Apr.

  PMID: 37220453 BACKGROUND

• Alabbas F, Dumant C. Outcomes of Blenderized Gastrostomy Feeding in Children at Rouen University Hospital. Pediatric Health Med Ther. 2022 Aug 10;13:271-277. doi: 10.2147/PHMT.S361724. eCollection 2022.

  PMID: 35983160 BACKGROUND

• Gallagher K, Flint A, Mouzaki M, Carpenter A, Haliburton B, Bannister L, Norgrove H, Hoffman L, Mack D, Stintzi A, Marcon M. Blenderized Enteral Nutrition Diet Study: Feasibility, Clinical, and Microbiome Outcomes of Providing Blenderized Feeds Through a Gastric Tube in a Medically Complex Pediatric Population. JPEN J Parenter Enteral Nutr. 2018 Aug;42(6):1046-1060. doi: 10.1002/jpen.1049. Epub 2018 Jan 16.

  PMID: 29338077 BACKGROUND

• Durnan, S., Kennedy, A., Kennedy, D., Stanley, R., Donohoe, S., Thomas S. & Constable, L. (2021) Practice Toolkit: The Use of Blended Diet with Enteral Feeding Tubes. British Dietetic Association

  BACKGROUND

• Campbell SM. An anthology of advances in enteral tube feeding formulations. Nutr Clin Pract. 2006 Aug;21(4):411-5. doi: 10.1177/0115426506021004411.

  PMID: 16870811 BACKGROUND

• Bonnes SL, Salonen BR, Hurt RT, McMahon MT, Mundi MS. Parenteral and Enteral Nutrition-From Hospital to Home: Will It Be Covered? Nutr Clin Pract. 2017 Dec;32(6):730-738. doi: 10.1177/0884533617734491. Epub 2017 Oct 10.

  PMID: 29016231 BACKGROUND

Related Links

• Link to the British Dietetic Association Policy Statement and Practice Toolkit on the use of blended diet with enteral feeding tubes
• Home page for Wilbo's Blends

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant's selection will be made by purposive sampling following the eligibility criteria and clinician/dietitians' recommendation. Participants will be invited into clinic or via the Home Enteral Feeding service home visits (in accordance with local practice) to consent.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: October 16, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)