Bolus tube feeding with blended foods: acceptability and tolerance

Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends

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

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (industry)
• Locations: 2 sites (Nottingham and 1 other locations)
• Trial ID: NCT07341464 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Nottingham and 1 other locations

• Queen Medical Hospital Nutrition and Dietetics — Nottingham, United Kingdom (NOT_YET_RECRUITING)
• Dietetic Team 1st floor Kings Court 1, Charles Hastings Way, — Worcester, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Sharan Saduera, BSc (Hons) Dietetics

Conditions: Cerebral Palsy, Oncology