Amino Acid Feed Children's Study
An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated conditions, over 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 1, 2017
October 1, 2017
1.9 years
June 10, 2015
October 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Gastro intestinal tolerance questionnaire
Gastro-intestinal tolerance will be recorded at baseline and on days 1, 2, 3 and 7 of week 1 of the study. During weeks 2 and 3 tolerance will be recorded once at the end of each week on days 14 and 21. During week 4, tolerance will be recorded on days 26, 27 and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer
4 weeks
Secondary Outcomes (7)
Compliance with feed prescription (amount prescribed versus consumed)
4 weeks
Product acceptability questionnaire
4 weeks
Nutrient intake (energy, protein and micronutrients)
4 weeks
Weight (kg)
4 weeks
Height (cm)
4 weeks
- +2 more secondary outcomes
Study Arms (1)
Amino Acid Feed
OTHERAn amino acid based multi-nutrient powdered feed
Interventions
Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days). The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management. The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.
Eligibility Criteria
You may qualify if:
- Male or female
- Age 1-10 years
- Currently using or requiring an amino acid based feed
- Expected to receive at least 30% of their energy intake from the study product
- Written informed consent from parents / carer
You may not qualify if:
- Parenteral nutrition contributing more than 70% of total energy intake
- Children with major hepatic or renal dysfunction
- Participation in other studies within 2 weeks prior to entry of this study
- Investigator concern around willingness/ability of parent/carer to comply with protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nutricia UK Ltdlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
June 10, 2015
First Posted
October 7, 2015
Study Start
November 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
November 1, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share