The aim of the study is to compare prevention (oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks) with treatment-as-needed (supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age). This is a single site pilot study to assess feasibility for a full trial.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Combined infant daily cry/fuss duration
Timeframe: Baseline
Combined infant daily cry/fuss duration
Timeframe: 6 weeks
Combined infant daily cry/fuss duration
Timeframe: 12 weeks