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Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends

Sponsor: Société des Produits Nestlé (SPN)

NCT ID: NCT07341464

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tube feed (supplement)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
Tube feed — supplement: Dose intake and duration.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
1 Year and over
Who
All
Number of participants
50
Started
2025-12-10
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for cerebral palsy (cp)
  • • NA - 50 participants
  • • This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants

Who can take part?

  • • Ages 1 Year and over
  • • Diagnosed with cerebral palsy (cp)

Where?

  • • Nottingham - Queen Medical Hospital Nutrition and Dietetics
  • • Worcester - Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants. The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.

More detail

The study will collect data in 50 children and adults over a period of 28 days. Gastrointestinal tolerance will be collected over 7 days and formula intake will be over 28 days. A patient satisfaction questionnaire will be completed at the end of the study.

Cerebral Palsy (CP)Oncology

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 1 Year and over
  • Who can join: All genders

What the study is looking for

  • ✓Patients well-established and stable on current enteral tube feed or home-made blended diet.
  • ✓Gastrostomy fed only.
  • ✓Willingly given, written, agreement to take part from patient/caregiver

Who cannot take part

  • ✗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.
See the full 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 Is This Study? (2 UK sites)

Queen Medical Hospital Nutrition and Dietetics

Nottingham NG7 2UH, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Sarah Durnan, PHD Dietetics07812277811s.durnan@nhs.net

Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,

Worcester WR5 1JR, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Sharan Saduera, BSc (Hons) Dietetics

Sponsor contact

CONTACT

+447557170649 sharan.saduera@uk.nestle.com

Sarah Durnan, PHD, BSc Nutrition Dietetics

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-01