Trial reportJournal of pediatric gastroenterology and nutrition2025
Effect of A1 protein-free formula versus conventional formula on acute respiratory infections and diarrhea in toddlers: A Randomized Controlled Trial.
Trial report in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Effect of A1 protein-free formula versus conventional formula on acute respiratory infections and diarrhea in toddlers: A Randomized Controlled Trial.Journal of pediatric gastroenterology and nutrition · 2025Trial
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
objectivesAcute respiratory infections (ARIs) and diarrhea are common in toddlers. Milk free of A1 β-casein (A1PF milk) may support the immune system, but few studies have investigated A1PF milk in toddler formula and any potential effects on ARI/diarrhea. This study's objective was to investigate the incidence of ARI and diarrhea with two toddler formulas, A1PF formula (A1PF) or conventional formula (CON), which differed in milk base and nutrient composition.
methodsThis randomized, open-label, multicenter study (19 December 2022 to 17 May 2023) evaluated the occurrence of ARI and/or diarrhea in toddlers (aged 2-3 years) who consumed A1PF or CON over 90 days.
resultsA total of 200 toddlers were enrolled, and 180 completed the study. The relative risk of ARI or diarrhea in the A1PF group versus the CON group did not differ significantly, but the median (interquartile range) ARI duration was significantly shorter in the A1PF group (3 [2-4] days vs. 5 [3-6] days, p = 0.012). At Day 90, toddlers consuming A1PF had significantly less severe bloating, gassiness, and fewer regurgitation events (all p < 0.05). Both formulas were well tolerated, and no serious adverse events were reported.
conclusionToddlers who consumed A1PF had a reduced duration of ARI and improved diarrhea outcomes, reducing the burden on their families compared with toddlers who consumed CON. Although this is consistent with other studies, further research is required to determine whether these effects are solely attributable to the A1PF milk base or other differences between the formulas.
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Registered trials
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