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

NCT03667118 | Completed DMC

• 1 other identifier: STU00205862
• Study Type: interventional
• Target: 705
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptom

  1 month

Study Arms (2)

Food Supplement

EXPERIMENTAL

Infants who received the active food supplement powder

Dietary Supplement: Food Supplement

Placebo

PLACEBO COMPARATOR

Infants who received the placebo powder

Dietary Supplement: Food Supplement

Interventions

Food Supplement DIETARY_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

Food Supplement; Placebo

Eligibility Criteria

• Age: 5 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Jane L Holl

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jane L Holl, MD MPH

  Professor of Pediatrics, Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Parents received packets of the powder to be fed from their infant directly from the manufacturer.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Healthcare Studies

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: June 18, 2017
• Primary Completion: October 9, 2017
• Study Completion: October 9, 2017
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)