Babies with suspected cow's milk allergy often struggle to find a food that lets them grow and feel well. This new research protocol looks at a specific formula made from hydrolyzed rice protein. It also includes special sugars called 2-fucosyllactose and lacto-N-neotetraose, which are naturally found in breast milk. The study compares this new option against an existing extensively hydrolyzed formula that contains the same special sugars. Both groups of babies received these formulas for four months after they joined the study. Researchers checked their growth, including weight, length, and head size. They also watched for allergy symptoms, stomach comfort, and how well the babies tolerated the food. Safety was monitored closely for any side effects or reasons to stop the formula. This trial takes place across multiple centers in Europe. The goal is to see if the new rice-based formula works just as well as the standard hydrolyzed option. Because this is a protocol, the final results are not yet available. The study design ensures that neither the parents nor the doctors knew which formula each baby received during the trial. This careful setup helps ensure the findings are fair and accurate.
Protocol for HRF-HMO vs eHF-HMO in infants with suspected cow's milk allergyNew formula protocol aims to help infants with suspected cow's milk allergy grow normally
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This study is a randomized controlled blinded multi-center trial protocol involving 104 healthy full-term formula-fed infants ≤ 8 months of age with physician-diagnosed or suspected cow's milk allergy. The trial is set in Europe. The intervention is a new hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose (HRF-HMO), compared with an extensively hydrolyzed formula containing 2-fucosyllactose and lacto-N-neotetraose (eHF-HMO). The primary outcome is age-appropriate growth, specifically weight-for-age z-score non-inferiority to the control. Secondary outcomes include length, head circumference, bone length, allergy symptoms, gastrointestinal tolerance, health-related quality of life, adverse events, and formula compliance. Follow-up is scheduled monthly until 4 months post-enrollment.
Safety and tolerability data, including adverse events, serious adverse events, discontinuations, and overall tolerability, are not reported in this protocol. Similarly, specific main results regarding growth metrics and other secondary outcomes are not available at this stage. Funding or conflicts of interest are not reported. Limitations specific to the protocol design are not detailed in the provided text.
Because this document is a protocol, no causal conclusions can be drawn regarding the efficacy or safety of HRF-HMO versus eHF-HMO. The practice relevance remains uncertain until the trial results are published. Clinicians should await final data before making recommendations based on this specific intervention.
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