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
- Conditions
- Enteral Nutrition (Food for Special Medical Purposes)Enteral FeedsEnteral Tube NutritionGastrostomy Tube
- Registration Number
- NCT07036081
- Lead Sponsor
- Nottingham University Hospitals NHS Trust
- Brief Summary
The goal of this observational study is to learn if tube-fed children and young people (age 3-16 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 3-16 years)
Participants will:
Take Wilbo's Blend+ for a 7 day period as part of their feeding plan Complete questionnaires about their gastrointestinal symptoms
- Detailed Description
THEORETICAL FRAMEWORK The study design follows the UK Advisory Committee on Borderline Substances (ACBS) criteria to support submission for prescription usage in the National Health Service (NHS).
RESEARCH QUESTION / AIM(S) Is a new nutritionally complete enteral formula based predominantly on real food ingredients accepted, tolerated and complied with instead of a patient's usual enteral feed.
Objectives Primary: To test the acceptability of Wilbo's Blends+ with regards to GI tolerance and compliance, following UK ACBS criteria to support submission for prescription usage in the NHS.
Secondary:
* To test ease of use of the Wilbo's Blends+ product.
* To test where possible palatability of the Wilbo's Blends+ product.
* To record the food, feed and fluid intake while taking Wilbo's Blends+ as part of a Dietitian prescribed enteral feeding plan.
* To collect data on Health Care Team perceptions of Wilbo's Blends+.
STUDY DESIGN AND METHODS OF DATA/SAMPLE COLLECTION AND DATA/SAMPLE ANALYSIS
Study Design The study design follows the UK Advisory Committee on Borderline Substances (ACBS) criteria to support submission for prescription usage in the NHS.
This will be a prospective, open-label single arm interventional study that will use participant/parent/carer-reported electronic questionnaires and records alongside electronic CRFs completed by the clinical team for data collection.
Methods of Data Collection The CI will assign participants with a study ID at the stage of consent. The demographic data should be stored only with the study ID on a password protected MSExcel spreadsheet with audit tracking. There will be a separate MSExcel spreadsheet which hold the key and individuals' names in case a participant needs to be re-identified. All participant questionnaires will be collected electronically using JISC and the study code. All data collected at the baseline visit and perceptions of the participant's clinical team prior to and following use of Wilbo's Blends+ will also be captured using JISC.
The clinical trial database will be developed by the Study Sponsor and made available online to participating sites. Access to the anonymised electronic database will be restricted to members of the study team. All study data will be destroyed after 15 years. Once participants have been recruited into the study, they will complete the questionnaire on typical GI pattern in preceding 3 days with the clinical team at the baseline visit. The GI tolerance records and compliance records for the 7 days when receiving Wilbo's Blends+ will be completed at home. In addition, the ease of use and palatability questionnaire will be completed at home at the end of the study.
STUDY SETTING This is a multicentre study with two recruiting sites - Nottingham University Hospitals NHS Trust and Manchester Foundation Trust.
Sampling technique 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.
Recruitment Participants will be identified by existing members of the participant's clinical care team as meeting the eligibility criteria during the participant's routine NHS care and via pre-screening patient lists. The clinical team will ask whether family/carers/participants are happy to be contacted and once this has been agreed they will be approached to take part by the Principal Investigator or Dietician (all approaching will have Good Clinical Practice training). There is no plan to recruit through publicity or patient identification centres.
Participants will be given an age-appropriate Participant Information Sheet and Consent form and invited back to clinic/home visit organised \> 24 hours after receipt to be screened and consented if eligibility criteria is met.
Sample identification Participants who meet the eligibility criteria will be identified by a member of their existing clinical care team through routine outpatient follow up or inpatient monitoring and provided with the Participant Information Sheet (PIS) (paper and electronic versions available). Potential participants will be contacted by phone no less than 24 hours after receiving the PIS and if they wish to consent a baseline visit will be arranged. Upon completion of consent and eligibility checks baseline assessments will be conducted and a dietetic plan incorporating Wilbo's Blends+ produced for the participant.
The Wilbo's Blends+ product will be distributed directly to the Participant's home address by Wilbo's Blends (and arrangements for this will be detailed in the Participant Information Sheet and Consent Form). Participants will receive the packages of Wilbo's Blends+ product with instructions, recommendations and contact information.
Consent Informed consent will be obtained prior to the participant undergoing any activities that are specifically for the purposes of the study.
There will be discussion between the potential participant and his/her legally acceptable representatives (parent/carer) and the Principal Investigator or nominated study representative as detailed on the study delegation log about the nature and objectives of the study and possible risks.
A study information leaflet will be provided which will have been reviewed by patients and public, will be approved by the Research Ethics Committee (REC), and meet local regulatory requirements and legal requirements. An information sheet for parent/carers alongside assent documents for children at various age levels (3-5, 7-11, 12-15) will be available. After a period of time \> 24 hours and with participants and their families provided with the opportunity to ask questions after receipt of the Participant Information Sheet, participants or parents/carers of participants will consent. This will be written consent on a paper form. At this stage parent/carers can also consent for the participant to receive a second recipe after a period of at least three days following the last meal of the first recipe.
Study Assessments Participants will take a minimum of 30% of their daily intake from Wilbo's Blends+ per day for 7 days.
If required clinically there is the option to transition participants onto Wilbo's Blends+ over 1-6 days before starting the prescribed amount at day 1.
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+).
Day 1 of receiving Wilbo's Blends+ can take place up to 14 days after the screening and consent visit as long as there have not been any changes in baseline symptoms or hospitalisations and the end of study questionnaire and visit can be up to up to 6 days after finishing Wilbo's Blends+.
After the 7 days of Wilbo's Blends+ participants return to their pre-study regimen.
Participants with missing data will be followed up for completion. If the data is not completed/returned then that participant will be replaced.
Long term follow-up assessments This is an acceptability study over a short intervention period. Following the end of study visit (at day 14-18 in clinic or over telephone/video) no long-term follow up is required.
Withdrawal Criteria Participants will be withdrawn from the study if they are admitted to hospital or unwell for any reason relating to their underlying medical condition during the 7 days of receiving Wilbo's Blends+.
If a participant is withdrawn from the study the reasons for withdrawal will be collected on the Case Report Form.
Participants who are withdrawn from the study will be replaced.
END OF STUDY DEFINITION The end of study is defined as the final data collection for the last recruited participant.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- <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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acceptability with regard to gastrointestinal tolerance Days 1-7 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.
- Secondary Outcome Measures
Name Time Method Ease of use Day 8 Parents/carers will be asked to complete a questionnaire using a hedonic scale. (Ease of use is positive if ≥3 )
To test where possible palatability of the Wilbo's Blends+ product. Day 8 Palatability is positive (≥5 on the hedonic scale).
Health Care Team perceptions of Wilbo's Blends+. September 25-March 26 We will seek feedback from healthcare professionals involved in the study using exploratory qualitative data
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