NCT03667118

Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals

Completed NA Last updated 13 March 2019

What this trial tests

NA trial testing Food Supplement in Food Allergy in 705 participants. Completed in 9 October 2017.

Timeline

18 June 2017

Primary endpoint
9 October 2017

9 October 2017

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	705
Start date	18 June 2017
Primary completion	9 October 2017
Estimated completion	9 October 2017
Sites	1 location across United States

Drugs / interventions tested

• Food Supplement

Conditions studied

• Food Allergy — all drugs for Food Allergy →

Sponsor

Northwestern University

Who can join

Adults 5 Months to 11 Months, any sex, with Food Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to test a food supplement to:

* Show that the food supplement is well tolerated and safe to feed to infants;
* Find out how often parents/caregivers feed their infants the food supplement;
* Find out how parents/caregivers usually add the food supplement to infants' regular solid or liquid food; and
* Learn what aspects of the food supplement are more or less attractive to infants and to parents/caregivers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized trial of the acceptability of a daily multi-allergen food supplement for infants.
   Holl JL, Bilaver LA, Finn DJ, Savio K. · · 2020 · cited 12× · PMID 32030829 · DOI 10.1111/pai.13223