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

Completed · Not applicable · Has a placebo group

Conditions studied: Food Allergy

In brief

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.

Key facts

Study ID

NCT03667118

Run by

Northwestern University

People needed

705

Starts

2017-06-18

Expected to finish

2017-10-09

Last updated by the study team

2019-03-13

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Jane L Holl — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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