Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-9
SponsorAzienda Ospedaliera Universitaria Policlinico "G. Martino"

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Verum
  • Active comparator

Treatment groups

150 Participants
are divided into 2 treatment groups