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SpoonfulONE for Infant Nutrition

Duke Clinical Research Institute, Durham, NC
Targeting 2 different conditionsSpoonfulONEN/AWaitlist AvailableResearch Sponsored by Before Brands, Inc

Study Summary

This trial is designed to study how best to introduce complementary foods to infants, either with or without eczema. Parents will use a mobile app to track their experiences and progress in feeding their infants.

Eligible Conditions
  • Infant Nutrition
  • Diet Variety

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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The participant's parent or guardian agrees to introduce and feed them common foods such as peanuts, cashews, eggs, sesame, and cod within the next year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
Secondary outcome measures
Convenience, score through a questionnaire
Diet diversity, score
Mean age of participants when first introduced to various food groups, measured through a questionnaire
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard diet with daily SpoonfulONEExperimental Treatment1 Intervention
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.
Group II: Standard dietActive Control1 Intervention
Participants will feed on a standard diet only, with no intervention, and complete questionnaires

Find a site

Who is running the clinical trial?

Before Brands, IncLead Sponsor
Duke Clinical Research InstituteOTHER
58 Previous Clinical Trials
228,512 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age cutoff for participants exceed 25 years old?

"This research project is seeking participants who are between 4 and 6 months of age."

Answered by AI

What criteria must individuals meet to qualify for this research endeavor?

"Eligible participants must have a varied diet and be at least 4 months old, but no older than 6. In total, 1500 individuals are being recruited for the trial."

Answered by AI

Is the enrollment process available for the experiment still ongoing?

"At this time, clinicaltrials.gov reveals that the study is recruiting for participants. This investigation was first advertised on April 9th 2021 and had a follow up edit on April 12th of the same year."

Answered by AI

To what extent are individuals participating in this research endeavor?

"Affirmative. The clinicaltrials.gov website confirms that this medical trial, initially posted on April 9th 2021, is still recruiting participants to join the study. 1500 patients have been allocated one location for their participation in the experiment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
2021. "Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803981.
~439 spots leftby Sep 2024
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