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Search / Trial NCT07036081

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

Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · Jun 17, 2025

Trial Information

Current as of July 05, 2025

Not yet recruiting

Keywords

Enteral Tube Feeding Gastrostomy Tube Enteral Nutrition Enteral Formula Enteral Feeds

ClinConnect Summary

This clinical trial is studying a new type of tube feeding called Wilbo's Blends+, which is made from real food ingredients and designed to provide complete nutrition for children and young people aged 3 to 16 who need to be fed through a tube inserted into their stomach (a gastrostomy tube). The main goal is to find out if these children and their families find Wilbo's Blends+ acceptable, easy to use, and if it sits well with their digestive system.

Children who might take part are those who have already been assessed by a doctor or dietitian as needing tube feeding through a gastrostomy and can get at least 30% of their daily nutrition from Wilbo's Blends+ for at least a week. During the study, participants will use Wilbo's Blends+ for 7 days as part of their regular feeding plan and will be asked to complete simple questionnaires about how they feel, especially regarding any stomach or digestion symptoms. Parents or carers can help answer these questions if the child is too young or unable to communicate well. This study is not yet recruiting participants, and certain children, like those with specific medical conditions or allergies, won’t be eligible. Overall, the study aims to see how well this real-food tube feed works in everyday use and if it could be a good option for kids who need tube feeding.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Children and young people (age 3-16) who are assessed by a Doctor or Dietitian as requiring enteral tube feeding via gastrostomy.
  • Are 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.
  • Exclusion Criteria:
  • \<3 years old
  • \>16 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 changes in current medication or use of additional macro and micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator.

About Nottingham University Hospitals Nhs Trust

Nottingham University Hospitals NHS Trust is a leading healthcare provider in the UK, dedicated to delivering high-quality patient care and advancing medical research. Comprising two major hospitals, Queen's Medical Centre and Nottingham City Hospital, the Trust is at the forefront of clinical innovation and education. With a strong emphasis on translational research, Nottingham University Hospitals NHS Trust actively sponsors clinical trials aimed at improving treatment outcomes and understanding various health conditions. The Trust collaborates with academic institutions, healthcare professionals, and industry partners to foster a robust research environment that enhances clinical practice and contributes to evidence-based medicine.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported