The INTENT Study

The Infancy to Toddlerhood: Early Nutrition and Tolerance (INTENT) study is a direct-to-participant digital health clinical trial evaluating SpoonfulONE as a complementary feeding strategy for early food allergen introduction in infants and toddlers.

The INTENT virtual study is randomized, controlled, and open-label. We enrolled infants between the ages of 4-6 months, including infants with eczema.

Participants are randomized to either feed SpoonfulONE daily, or non-intervention control allowing parent-led food allergen introduction. The study will follow infants for up to 18 months (until age 22-24 months).

The INTENT Study

The INTENT virtual study is randomized, controlled, and open-label. We enrolled infants between the ages of 4-6 months, including infants with eczema.

The INTENT Study Endpoints

Primary Endpoint

1

Proportion of babies able to tolerate 5 common foods (peanut, egg, cashew, cod, and sesame) after 12 months of feeding a multi-food allergen product

Secondary Endpoints

1

Parental comfort with introduction of potential food allergen introduction to their infants diet

2

Diet diversity in infants feeding on multi-food allergen product vs standard diet

3

Proportion of infants who have consumed a serving of each potential food allergen by month of age

4

To demonstrate that the product is easy to use regularly for 12 months

5

To demonstrate compliance with and adherence to daily feeding recommendations

6

Ability to tolerate the selected 9 common foods in the multi-food allergen product (peanut, milk, cashew, egg, cod, shrimp, wheat, soy, and sesame), after 12 months and 18 months of daily feeding

Study Design

INTENT Study Timeline

2021 Q1

Study Launch

Virtual study design
IRB approval
Online recruitment

2022 Q2

Recruitment Completed

1705 active babies at close of enrollment

496 with eczema (21.9%)

Data collected:
demographics, baseline comfort, reaction on first feeding

Ongoing data collection via surveys:
daily adherence, monthly diet diversity, quarterly comfort and convenience, tolerance at 12/18 months

2023 Q2

Primary Endpoint Reached

All participants complete primary endpoint at 12 months

Data collected:
tolerance at 12 months, diet diversity, comfort over time, convenience

Ongoing data collection via surveys:
daily adherence, monthly diet diversity, quarterly comfort and convenience, tolerance at 12/18 months

Q4 2023

Study Completion

All participants complete the study at 18 months

All data collected:
tolerance at 18 months, diet diversity, comfort over time, convenience

Questions?

The INTENT Study is funded by Before Brands, the inventor of SpoonfulONE.
The Duke Clinical Research Institute, which is part of Duke University, is coordinating the study operations.