Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    1500
  • sponsor
    Before Brands, Inc
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Updated on 19 April 2021
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Summary

This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.

Details
Condition infant nutrition, Diet Diversity
Treatment SpoonfulONE
Clinical Study IdentifierNCT04803981
SponsorBefore Brands, Inc
Last Modified on19 April 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female 4-6 months of age at time of consent
Provision of signed and dated informed consent form parent/guardian(s)
Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
In good general health as evidenced by medical history reported by the parent/guardian(s)
No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients

Exclusion Criteria

Known physician confirmed allergies to any of the ingredients in SO at the time of consent
Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
Sibling in the home is already enrolled in the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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