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Vegetarian Tube Feed Study (Tube feed)

N

Nestlé

Status

Not yet enrolling

Conditions

Paediatric

Treatments

Dietary Supplement: paediatric tube feed

Study type

Interventional

Funder types

Industry

Identifiers

NCT07378111
CPV tube feed PB002
IRAS ID 341165 (Other Identifier)

Details and patient eligibility

About

This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.

Full description

Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed with food derived ingredients. Gastrointestinal tolerance will data will be collected using a 4point Likert scale, daily record of tube feed volume intake.

Enrollment

25 estimated patients

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients from 1 -15 years requiring more than 50% of energy from tube feeding or to take alongside home-made blended diet as part of their dietary management for disease related malnutrition.
  • Patients well-established and stable on current nutritional support regimen. Willingly given, written, informed consent from patient/caregiver

Exclusion criteria

  • No established tube feed.
  • Inability to comply with the study protocol, in the opinion of the investigator.
  • Under 1 years of age
  • Patients on parenteral nutrition
  • Known food allergies, including to any ingredients listed in appendix 1.
  • Participation in another interventional study within 2 weeks of this study.
  • Patients with known or suspected ileus or mechanical bowel obstruction

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Children will act as their own control for the nutritional product
Experimental group
Description:
Gastrointestinal tolerance and daily formula intake over 28 days.
Treatment:
Dietary Supplement: paediatric tube feed

Trial contacts and locations

0

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Central trial contact

Sharan BSc (hons), Nutrition and Dietetics

Data sourced from clinicaltrials.gov

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