Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends (Blends)

January 6, 2026 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sarah Durnan, PHD, BSc Nutrition Dietetics

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Not yet recruiting
        • Queen Medical Hospital Nutrition and Dietetics
        • Contact:
        • Contact:
          • James Evans, BSc Dietetics
      • Worcester, United Kingdom, WR5 1JR
        • Recruiting
        • Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Acceptability and Tolerance Study of bolus tube feed with food blends
Arm one will act as their own controls
Dietary supplement: Tube feed
Dose intake and duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Gastrointestinal tolerance
Time Frame: 7 days
Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
7 days
Daily record of formula intake.
Time Frame: 28 days
Measure of formula intake in mL.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

November 11, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTB 001
  • IRAS ID 341165 (Other Identifier: Yorkshire & The Humber - South Yorkshire Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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