Verum: 1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Active comparator: 1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Study summary
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
Sex
ALL
Min age
0 Months
Max age
9 Months
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion 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
* suspected or confirmed food allergy to the ingredients of the products under study
* gastroesophageal reflux disease
* use of antibiotics 1-2 weeks before enrolment
* use of gastric acidity inhibitors at any time before enrolment
* fever and/or infectious diseases at any time before enrolment
* current systemic infections
* history of congenital infections
Primary outcome measure(s)
Evaluation of infant gastrointestinal discomfort and colics by measuring the medium full-force daily crying — T0 (first visit) - T1 (after 7 days) - T2 (after 15 days) - T3 (after 30 days) - T4 (after 60 days) The mean daily minutes of crying will be calculated as a sum of crying, fussing, and unsuitable crying using a parental diary.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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