NCT03718195

Brief Summary

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric 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; feeding intolerances, developmental disabilities, disease related malnutrition The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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 Start

First participant enrolled

August 21, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

August 19, 2020

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

August 22, 2018

Last Update Submit

August 17, 2020

Conditions

Child Nutrition Disorders

Outcome Measures

Primary Outcomes (2)

  • Gastrointestinal tolerance

    Incidence of gastrointestinal adverse effects. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study.

    Day 7 from baseline

  • Participant compliance

    Volume of test product prescribed versus actually taken

    Day 7 from baseline

Secondary Outcomes (1)

  • Body Weight

    Day 7 from baseline

Study Arms (1)

Pediatric formula

OTHER

Each child will receive a new formula for a period of seven days. The new formula is a nutritionally complete standard enteral tube feed, with ingredients derived from real food. The formula is a food for special medical purposes for use under medical supervision. The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube

Other: Pediatric Formula

Interventions

Pediatric FormulaOTHER

One week intake diary, one week tolerance diary, product intake

Pediatric formula

Eligibility Criteria

Age1 Year - 15 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Require a tube feed (taking \>75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
  • Paediatrics aged 1 year above.
  • Patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on current formula)
  • Willingly given, written, informed consent from patient or parent/guardian.
  • Willingly given, written assent (if appropriate).

You may not qualify if:

  • Inability to comply with the study protocol, in the opinion of the investigator
  • Known food allergies to any ingredients (see ingredients list)
  • Patients with significant renal or hepatic impairment
  • Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
  • Participation in another interventional study within 2 weeks of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Evelina Childrens Hospital

London, SE1 7EH, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

East Oxford Health Centre

Oxford, OX4 1XD, United Kingdom

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Clare Thornton-Wood, BSc

    Dietitian

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2018

First Posted

October 24, 2018

Study Start

August 21, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

August 19, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)