Bolus tube feeding with blended foods: acceptability and tolerance
Official title: Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
Run by Société des Produits Nestlé (SPN) · NCT07341464 · Data updated 2026-11-12
This 28-day test tries a bolus tube feed made from blended foods in children and adults with gastrostomy tubes to see if they tolerate it and will use it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Société des Produits Nestlé (SPN) Industry-sponsored |
| Locations | 2 sites (Nottingham and 1 other locations) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | November 10, 2026 |
| Study ends | November 11, 2026 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07341464 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Gastrostomy-fed children (age ≥1 year) and adults who are stable on enteral feeds or homemade blended diets and require at least one bolus feed are ideal candidates.
✕Probably not a fit
Patients with nasogastric or jejunal tubes, those on total parenteral nutrition, infants under 1 year, people with known food allergies, significant renal or hepatic impairment, or suspected bowel obstruction are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective acceptability and tolerance study will enroll up to 50 children and adults who receive gastrostomy feeds. Participants will replace one or more usual bolus feeds with the investigational blended enteral formula and record gastrointestinal symptoms daily, with tolerance data collected intensively over the first 7 days and intake/compliance tracked across 28 days. A patient satisfaction questionnaire will be completed at study end to capture palatability and ease-of-use; key exclusions include nasogastric/jejunal feeding, total parenteral nutrition, significant hepatic or renal impairment, known food allergies, or mechanical bowel obstruction. The sponsor is Nestlé and study procedures take place at dietetic sites in Nottingham and Worcester, UK.
Why it matters
Potential benefit: If successful, this could provide an acceptable bolus feeding option that improves nutritional intake and caregiver/patient satisfaction for people who use gastrostomy feeds.
How similar studies have gone: Observational reports of home-blended diets and commercial blenderized formulas report acceptable tolerance and high caregiver satisfaction in many cases, but randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition. * Patients well-established and stable on current enteral tube feed or home-made blended diet. * Gastrostomy fed only. * Willingly given, written, informed consent from patient/caregiver Exclusion Criteria: * Inability to comply with the study protocol, in the opinion of the investigator. * Under 1 years of age * Patients who have a nasogastric and jejunal feeding tubes * Patients on total parenteral nutrition * Known food allergies to any ingredients listed in appendix 1. * Patients with significant renal or hepatic impairment * Participation in another interventional study within 2 weeks of this study. * Patients with known or suspected ileus or mechanical bowel obstruction
Where it's running
-
Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
Worcester, United Kingdom Recruiting -
Queen Medical Hospital Nutrition and Dietetics
Nottingham, United Kingdom Not yet recruiting
Study contacts
- Study coordinator: Sharan Saduera, BSc (Hons) Dietetics
- Email: sharan.saduera@uk.nestle.com
- Phone: +447557170649
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.