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Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.

NCT03718208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-08-19

No results posted yet for this study

Summary

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae;

The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Conditions

  • Cerebral Palsy

Interventions

DIETARY_SUPPLEMENT

Paediatric Formula

Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Clare Thornton-Wood, BSc · Dietitian

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2019-07-22
Completion
2019-07-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718208 on ClinicalTrials.gov