The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species.
The main outcomes are: - the mean number of crying episodes and the sleep duration - Relative abundance of the gut microbiota probiotic treatment species.
Children Age: 0-9 months Infant colics diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability - preverbal patient pain scale) and G4 Infant Colic Rome IV criteria
infants suffering from acute or chronic diseases, such as chronic lung disease; diarrhea underlying specific diseases or developmental disorders confirmed by a pediatrician
infants participating in other clinical studies
age ≥ 9 months
neurological diseases
Parallel
Verum
Dietary supplement1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Active comparator
Dietary supplement1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Evaluation of infant gastrointestinal discomfort and colics by measuring the medium full-force daily crying
The mean daily minutes of crying will be calculated as a sum of crying, fussing, and unsuitable crying using a parental diary.
Evaluation of relative abundance of the gut microbiota probiotic treatment species
Relative abundance of the gut microbiota probiotic treatment species (L. reuteri and L. acidophilus) will be evaluated using quantitative PCR (Polymerase Chain Reaction), in order to identify the colonization ability of the study treatment.
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