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

Primary Purpose

Food Allergy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Food Supplement

About this trial

This is an interventional supportive care trial for Food Allergy

Eligibility Criteria

5 Months - 11 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Jane L Holl

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Food Supplement

Placebo

Arm Description

Infants who received the active food supplement powder

Infants who received the placebo powder

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symptom

difference between the proportion of infants with a symptom within 2 hours of ingestion of the food supplement versus placebo arm

Full Information

NCT ID

NCT03667118

First Posted

September 10, 2018

Last Updated

March 11, 2019

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT03667118

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 18, 2017 (Actual)

Primary Completion Date

October 9, 2017 (Actual)

Study Completion Date

October 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Parents received packets of the powder to be fed from their infant directly from the manufacturer.

Allocation

Randomized

Enrollment

705 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Food Supplement

Arm Type

Experimental

Arm Description

Infants who received the active food supplement powder

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Infants who received the placebo powder

Intervention Type

Dietary Supplement

Intervention Name(s)

Food Supplement

Intervention Description

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

Primary Outcome Measure Information:

Title

Allergic-type reaction

Description

difference between the proportion of infants with allergic-type reaction within 2 hours of ingestion in the food supplement versus placebo arm

Time Frame

1month

Secondary Outcome Measure Information:

Title

Symptom

Description

difference between the proportion of infants with a symptom within 2 hours of ingestion of the food supplement versus placebo arm

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Months

Maximum Age & Unit of Time

11 Months

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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: Does you infant have a health condition that has lasted for more than three (3) months? If yes, go to Question 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane L Holl, MD MPH

Organizational Affiliation

Professor of Pediatrics, Feinberg School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jane L Holl

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Demographic data about the study participants Outcomes of the study

Learn more about this trial

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

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