Plain-English translation of NCT05578716 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is testing two newly developed infant formulas in healthy babies to see how well they support growth and development. Researchers want to understand whether these new formulas—which use a special process called protein hydrolysis to break down proteins—are safe and effective compared to standard infant formula and breastfeeding. The study will also look at how these formulas affect allergies, the immune system, and baby's overall health.
Standard infant formula has higher protein content than breast milk, which can lead to faster weight gain and higher risk of childhood obesity. While the new treatment has been developed to provide better nutrition and possibly prevent allergies, researchers haven't yet studied how well these new formulas work in healthy babies without a family history of allergies.
You likely qualify if…
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If you formula-feed, your baby will be randomly assigned to receive either one of the two new study formulas or standard formula. If you breastfeed, your baby will be in the reference group. Throughout the study, researchers will monitor your baby's growth, collect health information, and possibly take samples to measure immune markers and gut bacteria. The study is designed to follow healthy infants over time and compare outcomes across the different feeding groups.
AI-generated summary from trial data · Jun 3, 2026 · Not medical advice
Sweden
Sponsor
Umeå University
Collaborators
Lund University, Arla Foods
Enrollment target
~312 participants
Started
October 2022
Primary completion
June 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
4 Weeks – 8 Weeks
Last updated on clinicaltrials.gov in December 2023.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Magnus Domellöf, MD, PhD
Department of Clinical Sciences, Pediatrics, Umeå University Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.