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

Daily Ingestion of a Multi-Allergen Food Supplement by Infants: Clinical Symptoms, Reactions, and Acceptability - A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Dietary supplement: Food Supplement

Detailed Description

The study involves parents/caregivers of infants, ≥ 5 months but < 11 months of age. Parents who enrolled their infants complete a 1-month blinded placebo run-in period, followed by randomization to placebo or the food supplement.

During the intervention period, infants randomized to the food supplement are fed a once daily, individual packet of the food supplement mixed into liquid (e.g., breast milk, infant formula) or solid (e.g., applesauce, pureed carrots) foods being fed to the infant. The food supplement is a blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3. Parents complete a daily diary about any reactions or symptoms within 2 hours of ingesting the food supplement. Infants randomized to the placebo are also fed a once daily individual packet of the placebo mixed into liquid or solid foods being fed to the infant. Parents also complete a daily diary about any reactions or symptoms within 2 hours of ingesting the placebo.

• Study Type: Interventional
• Enrollment (Actual): 705
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Jane L Holl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 11 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy infants, ≥ 5 months but < 11 months of age whose parent/caregiver can provide, in English, consent, understand instructions and complete a daily diet diary for their child, answer questions about how much and in what food they mix the Food supplement, and report any reaction or adverse event. Pregnant women will not be excluded if they have a child who is eligible for the study.

Exclusion Criteria:

• - Any parent/caregiver who cannot provide consent.
• Any parent/caregiver who cannot understand or write English.
• A parent/caregiver who is in prison.

• Any infant who

  • Has a previous or current diagnosis of food allergy, made by a board-certified allergy and immunology specialist;
  • Was born before 37 weeks of pregnancy (premature birth);

  • Has severe eczema, as determined by two parent/caregiver questions:

    1. During the past 6-11months, have you been told by a doctor or other health professional that your infant has eczema or any kind of skin allergy? (National Health Interview Survey, 2012) If yes, go to Question 2.
    2. Would you describe (his/her) eczema or skin allergy as mild, moderate, or severe? (National Survey of Children's Health, 2007) If described as severe, infant is excluded.

  • Has a current serious, chronic condition, as measured by:

    1. Does you infant have a health condition that has lasted for more than three (3) months? If yes, go to Question 2.
    2. Has your infant been hospitalized more than 2 times since birth for this condition? If yes to Question 1 and 2, infant is excluded.
• If a parent/caregiver has multiple birth infants (e.g., twins), only one eligible infant will be selected.
• Any person who works for Before Brands or who has a family member working for Before Brands.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food Supplement; Infants who received the active food supplement powder	Dietary supplement: Food Supplement; A powder blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3
Placebo Comparator: Placebo; Infants who received the placebo powder	Dietary supplement: Food Supplement; A powder blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergic-type reaction	difference between the proportion of infants with allergic-type reaction within 2 hours of ingestion in the food supplement versus placebo arm	1month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom	difference between the proportion of infants with a symptom within 2 hours of ingestion of the food supplement versus placebo arm	1 month

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jane L Holl, MD MPH, Professor of Pediatrics, Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2017
• Primary Completion (Actual): October 9, 2017
• Study Completion (Actual): October 9, 2017

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: STU00205862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Demographic data about the study participants Outcomes of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No