Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Before Brands

Status: Unknown

Conditions: Infant Nutrition; Diet Diversity

Treatments: Other: SpoonfulONE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04803981

SF-003

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Known physician confirmed allergies to any of the ingredients in SO at the time of consent
2. Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge)
3. Participant or parent/guardian unsuitable for the study, at the discretion of the investigator
4. Sibling in the home is already enrolled in the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Standard diet with daily SpoonfulONE

Experimental group

Description:

Participants will receive one serving of SO (one of three possible forms of SO: mix-ins, puffs, or crackers) daily in addition to a standard diet. The SO form fed on a given day will be at the discretion of the parent/guardian.

Treatment:

Other: SpoonfulONE

Standard diet

No Intervention group

Description:

Participants will feed on a standard diet only, with no intervention, and complete questionnaires