Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Allergy, Food Studies |
| Therapuetic Areas: | Otolaryngology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/15/2019 |
| Start Date: | June 18, 2017 |
| End Date: | October 9, 2017 |
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.
- 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.
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.
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.
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.
We found this trial at
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