NCT05269992

Brief Summary

A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
May 2022Dec 2028

First Submitted

Initial submission to the registry

February 16, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

February 16, 2022

Last Update Submit

April 9, 2026

Conditions

Malnutrition, Child

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal tolerance assessing abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence

    Gastrointestinal tolerance will be assessed at baseline (day 1) in relation to patients' usual enteral tube feed, oral nutritional supplement or other nutritional regimen, and again at day 8, 15, 22 and 29 during the intervention using standardised questionnaires.Parents/carers will be asked to complete a gastrointestinal symptom score form on behalf of their child which will assess the incidence and severity of the following symptoms: abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence on a four-point scale (Absent, Mild, Moderate, Severe).

    29 days

Secondary Outcomes (8)

  • Compliance

    29 days

  • Functionality, perception and satisfaction with the study product

    29 days

  • Energy and protein intake

    29 days

  • Gastrointestinal health-related quality of life

    29 days

  • Height

    29 days

  • +3 more secondary outcomes

Study Arms (1)

Real food products

EXPERIMENTAL

The study products are 1) a 1kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed; 2) a 1.5kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed, and 3) a 1.5kcal/ml oral nutritional supplement provided in a 200ml ready to drink format. This study is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period aiming to recruit 60 in paediatric patients. During the intervention period, patients will receive one of the three study products (or more if deemed appropriate) for 28 days as a sole source of nutrition or alongside any additional routine nutritional management as required. As such, randomisation was not deemed suitable for this study. The appropriate study product and volume prescribed will be recommended by the investigating dietitian/nurse and agreed with the patient/parent/carer based on their clinical and nutritional requirements.

Other: Real food products

Interventions

Real food productsOTHER

As per arm/group descriptions.

Real food products

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from 1 year to 16 years of age.
  • Requiring oral or enteral nutritional support from a whole protein 1kcal/ml or a 1.5kcal/ml enteral tube feed (via an existing enteral feeding tube) or oral nutritional supplement for at least 28 days.
  • Expected to receive a minimum of 300kcal/day from the study product(s).
  • Informed consent obtained from the patient/carer.

You may not qualify if:

  • Total parenteral nutrition (100% of requirements).
  • Allergy to any of the study product ingredients.
  • Severe galactose (galactosaemia) or lactose intolerance.
  • Severe hepatic, metabolic or renal dysfunction.
  • Requirement for a fibre free feed.
  • Requirement for a hydrolysed, elemental or any other specialised feed.
  • On high intensity chemotherapy or radiation therapy, pancreatitis, chylothorax, or Inflammatory Bowel Disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 8, 2022

Study Start

May 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No IPD planned. Following completion of this trial, the results may be published in conference proceedings or as a full manuscript where all data will be mean +/- SD and not individual.

Locations

GB(1)